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    Clinical Trial Results:
    Safety during use of paediatric triple chamber bag formulas administered IV at a weight dependant dose during 5 consecutive days in paediatric patients up to 18 years requiring parenteral nutrition. A prospective, multicentre, non-comparative phase III study in therapeutic use.

    Summary
    EudraCT number
    		 2007-001378-97
    Trial protocol
    		 FR   BE  
    Global end of trial date
    22 Dec 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Dec 2017
    First version publication date
    01 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Ped3CB/P01/06/Mu.B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01304394
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Baxter Healthcare Corporation
    Sponsor organisation address
    1 Baxter Parkway, Deerfield, United States, 60015
    Public contact
    Clinical Trials Disclosure Group, Baxter Healthcare Corporation, joe_archer@Baxter.com
    Scientific contact
    Clinical Trials Disclosure Group, Baxter Healthcare Corporation, joe_archer@Baxter.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Dec 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Dec 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2008
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the performance safety of the Ped3CB in paediatric patients.
    Protection of trial subjects
    Patients with a life expectancy < 6 days or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation were not included in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 43
    Country: Number of subjects enrolled
    France: 118
    Worldwide total number of subjects
    161
    EEA total number of subjects
    161
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    115
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    28
    Children (2-11 years)
    18
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No randomization occurred for this study.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 300 mL
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ped3CB
    Investigational medicinal product code
    Other name
    Numeta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mL bag: Formula for preterm infants, containing 9.4 grams amino acids, 40 grams glucose, 7.5 grams lipids, and electrolytes. Non-activation of the lipid peel seal would result in a 240 mL bag containing 9.4 grams amino acid, 40 grams glucose, and electrolytes. The dose was adapted to patient age, calorie/protein estimated needs and oral/enteral intakes, according to current ESPEN-ESPGHAN nutritional guidelines.

    Arm title
    		 500 mL
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ped3CB
    Investigational medicinal product code
    Other name
    Numeta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mL bag: Formula for term infants and toddlers <2 years of age, containing 13 grams amino acids, 77.5 grams glucose, 15.5 grams lipids, and electrolytes. Non-activation of the lipid peel seal would result in a 376 mL bag containing 13 grams amino acid, 77.5 grams glucose, and electrolytes. The dose was adapted to patient age, calorie/protein estimated needs and oral/enteral intakes, according to current ESPEN-ESPGHAN nutritional guidelines.

    Arm title
    		 1000 mL
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ped3CB
    Investigational medicinal product code
    Other name
    Numeta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mL bag: Formula for children and adolescents containing 23 grams amino acids, 191.5 grams glucose, 28.1 grams lipids, and electrolytes. Non-activation of the lipid peel seal would result in a 775 mL bag containing 23 grams amino acid, 191.5 grams glucose, and electrolytes. The dose was adapted to patient age, calorie/protein estimated needs and oral/enteral intakes, according to current ESPEN-ESPGHAN nutritional guidelines.

    Number of subjects in period 1
    		300 mL 500 mL 1000 mL
    Started
    115
    28
    18
    Exposed with at least 1 day of treatment
    113
    28
    18
    Completed
    97
    23
    13
    Not completed
    18
    5
    5
         Physician decision
    2
    4
    3
         Consent withdrawn by subject
    1
    -
    -
         Adverse event, non-fatal
    3
    -
    1
         Incurrent Illness
    2
    -
    -
         Enrolled but not treated
    2
    -
    -
         Protocol deviation
    8
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    300 mL
    Reporting group description
    		 -

    Reporting group title
    500 mL
    Reporting group description
    		 -

    Reporting group title
    1000 mL
    Reporting group description
    		 -

    Reporting group values
    		 300 mL 500 mL 1000 mL Total
    Number of subjects
    		 115 28 18 161
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 115 0 0 115
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 28 0 28
        Children (2-11 years)
    		 0 0 18 18
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 47 8 11 66
        Male
    		 68 20 7 95

    End points

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    End points reporting groups
    Reporting group title
    300 mL
    Reporting group description
    		 -

    Reporting group title
    500 mL
    Reporting group description
    		 -

    Reporting group title
    1000 mL
    Reporting group description
    		 -

    Primary: Systolic Blood Pressure by Visit

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    End point title
    		 Systolic Blood Pressure by Visit [1]
    End point description
    First recording in the morning, and a final evaluation will take place after the last infusion (including early/premature terminations before Day 5).
    End point type
    Primary
    End point timeframe
    Day 0 (Baseline) to Day 5
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    112
    25
    18
    Units: mmHg
    arithmetic mean (standard deviation)
        Day 0 (Baseline)
    60.5 ± 9.2
    76.4 ± 13.8
    106.4 ± 12.0
        Day 1
    61.8 ± 8.7
    77.7 ± 15.4
    109.3 ± 9.8
        Day 2
    60.8 ± 8.1
    78.5 ± 14.9
    111.4 ± 15.7
        Day 3
    61.7 ± 9.9
    80.0 ± 15.3
    106.0 ± 15.9
        Day 4
    61.4 ± 9.0
    81.4 ± 16.1
    104.2 ± 12.5
        Day 5
    63.2 ± 11.1
    86.9 ± 14.1
    110.0 ± 13.6
        Day 5 and Premature Terminations
    62.9 ± 11.5
    85.4 ± 13.4
    108.3 ± 13.8
    No statistical analyses for this end point

    Primary: Diastolic Blood Pressure by Visit

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    End point title
    		 Diastolic Blood Pressure by Visit [2]
    End point description
    First recording in the morning, and a final evaluation will take place after the last infusion (including early/premature terminations before Day 5).
    End point type
    Primary
    End point timeframe
    Day 0 (Baseline) to Day 5
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    112
    25
    18
    Units: mmHg
    arithmetic mean (standard deviation)
        Day 0 (Baseline)
    36.1 ± 7.8
    43.5 ± 10.8
    64.6 ± 9.6
        Day 1
    36.8 ± 8.8
    44.5 ± 11.9
    63.3 ± 9.1
        Day 2
    35.7 ± 7.8
    43.0 ± 11.1
    67.3 ± 12.1
        Day 3
    36.6 ± 8.3
    44.5 ± 9.2
    62.6 ± 10.9
        Day 4
    35.8 ± 8.5
    44.2 ± 9.1
    64.9 ± 8.7
        Day 5
    36.6 ± 9.7
    46.7 ± 9.8
    62.0 ± 10.2
        Day 5 and Premature Terminations
    36.6 ± 10.0
    46.8 ± 9.1
    63.5 ± 10.7
    No statistical analyses for this end point

    Primary: Heart Rate by Visit

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    End point title
    		 Heart Rate by Visit [3]
    End point description
    First recording in the morning, and a final evaluation will take place after the last infusion (including early/premature terminations before Day 5).
    End point type
    Primary
    End point timeframe
    Day 0 (Baseline) to Day 5
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: bpm
    arithmetic mean (standard deviation)
        Day 0 (Baseline)
    147.5 ± 15.9
    142.0 ± 22.9
    107.7 ± 27.8
        Day 1
    151.9 ± 14.5
    142.1 ± 23.0
    104.3 ± 29.1
        Day 2
    152.4 ± 14.8
    142.4 ± 21.5
    108.0 ± 25.3
        Day 3
    153.5 ± 14.1
    148.4 ± 16.9
    105.8 ± 27.9
        Day 4
    153.1 ± 13.9
    143.1 ± 17.4
    112.7 ± 33.2
        Day 5
    155.9 ± 13.6
    146.5 ± 15.9
    101.9 ± 32.4
        Day 5 and Premature Terminations
    155.5 ± 14.3
    148.5 ± 19.2
    101.6 ± 30.4
    No statistical analyses for this end point

    Primary: Temperature by Visit

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    End point title
    		 Temperature by Visit [4]
    End point description
    First recording in the morning, and a final evaluation will take place after the last infusion (including early/premature terminations before Day 5).
    End point type
    Primary
    End point timeframe
    Day 0 (Baseline) to Day 5
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    112
    28
    18
    Units: Celsius temperature
    arithmetic mean (standard deviation)
        Day 0 (Baseline)
    36.7 ± 0.4
    36.9 ± 0.5
    37.2 ± 0.9
        Day 1
    36.8 ± 0.4
    36.8 ± 0.5
    37.0 ± 0.9
        Day 2
    36.8 ± 0.4
    36.9 ± 0.6
    37.1 ± 0.8
        Day 3
    36.7 ± 0.4
    37.0 ± 0.4
    36.9 ± 0.6
        Day 4
    36.8 ± 0.4
    36.9 ± 0.4
    37.0 ± 1.0
        Day 5
    36.8 ± 0.5
    37.0 ± 0.3
    36.9 ± 1.1
        Day 5 and Premature Terminations
    36.8 ± 0.4
    36.9 ± 0.3
    37.0 ± 1.0
    No statistical analyses for this end point

    Primary: Number of Patients with Adverse Events (AE) and Serious Adverse Events (SAE)

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    End point title
    		 Number of Patients with Adverse Events (AE) and Serious Adverse Events (SAE) [5]
    End point description
    End point type
    Primary
    End point timeframe
    Day 0 (Baseline) through Day 5, or through Day 10 (optional for preterm newborn infants), with an additional 2 day follow-up period after the last infusion.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: Patients
        AE
    77
    18
    10
        SAE
    4
    0
    1
    No statistical analyses for this end point

    Primary: Total Number of Adverse Events (AE) and Serious Adverse Events (SAE) in Study

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    End point title
    		 Total Number of Adverse Events (AE) and Serious Adverse Events (SAE) in Study [6]
    End point description
    End point type
    Primary
    End point timeframe
    Day 0 (Baseline) through Day 5, or through Day 10 (optional for preterm newborn infants), with an additional 2 day follow-up period after the last infusion.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: Events
        AE
    167
    23
    17
        SAE
    6
    0
    2
    No statistical analyses for this end point

    Primary: Change from Baseline of Laboratory Parameters in Preterm Newborn Infant Group at Day 5

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    End point title
    		 Change from Baseline of Laboratory Parameters in Preterm Newborn Infant Group at Day 5 [7] [8]
    End point description
    * One patient had a phosphates value at Baseline at non-physiological level, so included parameter analysis without this patient.
    End point type
    Primary
    End point timeframe
    Day 0 (Baseline) and Day 5
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 300 mL
    Number of subjects analysed
    113
    Units: mmol/L
    arithmetic mean (standard deviation)
        Triglycerides (n=85)
    0.16 ± 1.17
        Urea (n=93)
    -0.87 ± 6.97
        Glucose (n=90)
    0.18 ± 2.32
        Sodium (n=94)
    -2.32 ± 4.24
        Potassium (n=92)
    0.51 ± 0.98
        Calcium (n=92)
    0.16 ± 0.31
        Phosphates (n=92)
    -0.31 ± 2.28
        Phosphates Excluding One Patient (n=91)*
    -0.07 ± 0.45
        Bicarbonates (n=86)
    4.70 ± 4.63
    No statistical analyses for this end point

    Primary: Change from Baseline of Laboratory Parameters in Preterm Newborn Infant Group at Day 10 or End of Treatment

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    End point title
    		 Change from Baseline of Laboratory Parameters in Preterm Newborn Infant Group at Day 10 or End of Treatment [9] [10]
    End point description
    * One patient had a phosphates value at Baseline at non-physiological level, so included parameter analysis without this patient.
    End point type
    Primary
    End point timeframe
    Day 0 (Baseline) and Day 10 or End of Treatment
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 300 mL
    Number of subjects analysed
    113
    Units: mmol/L
    arithmetic mean (standard deviation)
        Triglycerides (n=68)
    -0.10 ± 1.22
        Urea (n=77)
    -3.94 ± 6.44
        Glucose (n=77)
    -0.59 ± 1.67
        Sodium (n=82)
    -2.97 ± 4.6
        Potassium (n=80)
    0.44 ± 0.88
        Calcium (n=82)
    0.11 ± 0.29
        Phosphates (n=77)
    0.04 ± 0.53
        Phosphates Excluding One Patient (n=77)*
    0.04 ± 0.53
        Bicarbonates (n=73)
    3.85 ± 4.65
    No statistical analyses for this end point

    Primary: Change from Baseline of Laboratory Parameters in Preterm Newborn Infant Group at End of Treatment

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    End point title
    		 Change from Baseline of Laboratory Parameters in Preterm Newborn Infant Group at End of Treatment [11] [12]
    End point description
    * One patient had a phosphates value at Baseline at non-physiological level, so included parameter analysis without this patient.
    End point type
    Primary
    End point timeframe
    Day 0 (Baseline) and End of Treatment (including Premature Terminations and Completers)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 300 mL
    Number of subjects analysed
    113
    Units: mmol/L
    arithmetic mean (standard deviation)
        Triglycerides (n=91)
    -0.12 ± 1.34
        Urea (n=103)
    -3.14 ± 6.80
        Glucose (n=103)
    -0.48 ± 2.12
        Sodium (n=110)
    -2.72 ± 4.72
        Potassium (n=108)
    0.44 ± 1.00
        Calcium (n=106)
    0.12 ± 0.30
        Phosphates (n=102)
    -0.17 ± 2.20
        Phosphates Excluding One Patient (n=101)*
    0.04 ± 0.51
        Bicarbonates (n=99)
    3.75 ± 4.45
    No statistical analyses for this end point

    Secondary: Mean Daily Parenteral Intakes coming from Infused Ped3CB Bags

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    End point title
    		 Mean Daily Parenteral Intakes coming from Infused Ped3CB Bags
    End point description
    Safety population was used in this analysis. For the 3 treatment groups 300 mL, 500 mL, 1000 mL, the following are the mean body weight (grams) and mean total bag volume infused (mL/kg/day), respectively: 300 mL=1451 grams and 89.5 mL/kg/day; 500 mL= 3400 grams and 77 mL/kg/day); 1000 mL=31304 grams and 34 mL/kg/day. Also, the following is the ESPEN-ESPGHAN recommended ranges for the following parameters by treatment group: 300 mL bag=Total Bag volume infused:60-180 mL/kg/day, Amino acids:1.5-4 g/kg/day, Glucose:6-12 g/kg/day(up to 18), Lipids:1.25-3(up to 4) g/kg/day; 500 mL bag=Total Bag volume infused:80-150 mL/kg/day, Amino acids:1-2.5 g/kg/day, Glucose:8-16(up to 18) g/kg/day, Lipids:0.5-3(up to 4) g/kg/day; 1000 mL bag=Total Bag volume infused:50-100 mL/kg/day, Amino acids:1-2(up to 3) g/kg/day, Glucose:3-16 g/kg/day, Lipids:0.5-2(up to 3) g/kg/day.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: g/kg/day
    arithmetic mean (standard deviation)
        Nitrogen
    0.42 ± 0.11
    0.31 ± 0.09
    0.12 ± 0.07
        Amino Acids
    2.83 ± 0.76
    2.10 ± 0.61
    0.81 ± 0.45
        Glucose
    12.07 ± 3.24
    12.51 ± 3.63
    6.70 ± 3.77
        Lipids
    2.15 ± 0.66
    2.05 ± 0.99
    0.86 ± 0.67
    No statistical analyses for this end point

    Secondary: Mean Daily Parenteral Intakes (Energy) coming from Infused Ped3CB Bags

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    End point title
    		 Mean Daily Parenteral Intakes (Energy) coming from Infused Ped3CB Bags
    End point description
    Safety population was used in this analysis. This analysis focuses on Energy parameters of parenteral intakes. For the 3 treatment groups 300 mL, 500 mL, 1000 mL, the following are the mean body weight (grams) and mean total bag volume infused (mL/kg/day), respectively: 300 mL=1451 grams and 89.5 mL/kg/day; 500 mL= 3400 grams and 77 mL/kg/day); 1000 mL=31304 grams and 34 mL/kg/day. Also, the following is the ESPEN-ESPGHAN recommended ranges for the Total Calories by treatment group: 300 mL: 100 -120 (calculated: 43-94; up to 128) kcal/kg/day, 500 mL: 90 -100 (calculated: 41-104; up to 122) kcal/kg/day, 1000 mL: 30 -90 (calculated: 21-90; up to 102) kcal/kg/day.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: kcal/kg/day
    arithmetic mean (standard deviation)
        Total calories
    81.2 ± 21.5
    78.9 ± 21.6
    38.6 ± 23.1
        Non-protein calories
    69.8 ± 18.5
    70.5 ± 19.5
    35.4 ± 21.3
        Glucose calories
    48.29 ± 12.96
    50.03 ± 14.51
    26.80 ± 15.09
        Lipid calories
    21.51 ± 6.62
    20.46 ± 9.87
    8.55 ± 6.68
    No statistical analyses for this end point

    Secondary: Mean Daily Parenteral Intakes (Electrolytes) coming from Infused Ped3CB Bags

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    End point title
    		 Mean Daily Parenteral Intakes (Electrolytes) coming from Infused Ped3CB Bags
    End point description
    This analysis focuses on Electrolyte parameters of parenteral intakes. For the 3 treatment groups 300 mL, 500 mL, 1000 mL, the following are the mean body weight (grams) and mean total bag volume infused (mL/kg/day), respectively: 300 mL=1451 grams and 89.5 mL/kg/day; 500 mL= 3400 grams and 77 mL/kg/day); 1000 mL=31304 grams and 34 mL/kg/day. The following is the ESPEN-ESPGHAN recommended ranges for the following parameters by treatment group: 300 mL= Sodium: 0-5(up to 7) mmol/kg/day, Potassium: 0-5 mmol/kg/day, Magnesium: not provided, Calcium: 1-4 mmol/kg/day, Phosphate: 0.75-3 mmol/kg/day, Chloride: not provided; 500 mL= Sodium: 2-3 mmol/kg/day, Potassium: 1-3 mmol/kg/day, Magnesium: 0.1-0.2 mmol/kg/day, Calcium: 0.2-0.8 mmol/kg/day, Phosphate: 0.2-0.5 mmol/kg/day, Chloride: not provided; 1000 mL= Sodium: 1-3 mmol/kg/day, Potassium: 1-3 mmol/kg/day, Magnesium: 0.1 mmol/kg/day, Calcium: 0.2 mmol/kg/day, Phosphate: 0.2 mmol/kg/day, Chloride: not provided.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: mmol/kg/day
    arithmetic mean (standard deviation)
        Sodium
    1.93 ± 0.52
    1.84 ± 0.53
    1.57 ± 0.88
        Potassium
    1.87 ± 0.50
    1.84 ± 0.53
    1.12 ± 0.63
        Magnesium
    0.390 ± 0.105
    0.258 ± 0.074
    0.091 ± 0.052
        Calcium
    1.14 ± 0.31
    0.50 ± 0.15
    0.13 ± 0.08
        Phosphate
    1.13 ± 0.30
    0.67 ± 0.18
    0.33 ± 0.20
        Chloride
    2.80 ± 0.75
    2.26 ± 0.65
    1.50 ± 0.84
    No statistical analyses for this end point

    Secondary: Maximum Daily Parenteral Intakes coming from Infused Ped3CB Bags

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    End point title
    		 Maximum Daily Parenteral Intakes coming from Infused Ped3CB Bags
    End point description
    Safety population was used in this analysis. For the 3 treatment groups 300 mL, 500 mL, 1000 mL, the following are the mean body weight (grams) and mean total bag volume infused (mL/kg/day), respectively: 300 mL=1389 grams and 114.3 mL/kg/day; 500 mL= 3338 grams and 95.3 mL/kg/day); 1000 mL=31037 grams and 39.3 mL/kg/day. Also, the following is the ESPEN-ESPGHAN recommended ranges for the following parameters by treatment group: 300 mL bag=Total Bag volume infused:60-180 mL/kg/day, Amino acids:1.5-4 g/kg/day, Glucose:6-12 g/kg/day(up to 18), Lipids:1.25-3(up to 4) g/kg/day; 500 mL bag=Total Bag volume infused:80-150 mL/kg/day, Amino acids:1-2.5 g/kg/day, Glucose:8-16(up to 18) g/kg/day, Lipids:0.5-3(up to 4) g/kg/day; 1000 mL bag=Total Bag volume infused:50-100 mL/kg/day, Amino acids:1-2(up to 3) g/kg/day, Glucose:3-16 g/kg/day, Lipids:0.5-2(up to 3) g/kg/day.
    End point type
    Secondary
    End point timeframe
    Day 1 - Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: g/kg/day
    arithmetic mean (standard deviation)
        Nitrogen
    0.54 ± 0.13
    0.37 ± 0.10
    0.14 ± 0.07
        Amino Acids
    3.62 ± 0.87
    2.56 ± 0.68
    0.93 ± 0.49
        Glucose
    15.40 ± 3.70
    15.26 ± 4.07
    7.73 ± 4.08
        Lipids
    2.74 ± 0.83
    2.67 ± 1.20
    1.00 ± 0.73
    No statistical analyses for this end point

    Secondary: Maximum Daily Parenteral Intakes (Energy) coming from Infused Ped3CB Bags

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    End point title
    		 Maximum Daily Parenteral Intakes (Energy) coming from Infused Ped3CB Bags
    End point description
    Safety population was used in this analysis. This analysis focuses on Energy parameters of parenteral intakes. For the 3 treatment groups 300 mL, 500 mL, 1000 mL, the following are the mean body weight (grams) and mean total bag volume infused (mL/kg/day), respectively: 300 mL=1389 grams and 114.3 mL/kg/day; 500 mL= 3338 grams and 95.3 mL/kg/day); 1000 mL=31037 grams and 39.3 mL/kg/day. Also, the following is the ESPEN-ESPGHAN recommended ranges for the Total Calories by treatment group: 300 mL: 100 -120 (calculated: 43-94; up to 128) kcal/kg/day, 500 mL: 90 -100 (calculated: 41-104; up to 122) kcal/kg/day, 1000 mL: 30 -90 (calculated: 21-90; up to 102) kcal/kg/day.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: kcal/kg/day
    arithmetic mean (standard deviation)
        Total calories
    103.7 ± 23.6
    97.9 ± 26
    44.6 ± 25.1
        Non-protein calories
    89 ± 20.3
    87.7 ± 23.6
    40.9 ± 23.1
        Glucose calories
    61.59 ± 14.79
    61.03 ± 16.28
    30.91 ± 16.31
        Lipid calories
    27.43 ± 8.29
    26.65 ± 11.98
    10 ± 7.32
    No statistical analyses for this end point

    Secondary: Maximum Daily Parenteral Intakes (Electrolytes) coming from Infused Ped3CB Bags

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    End point title
    		 Maximum Daily Parenteral Intakes (Electrolytes) coming from Infused Ped3CB Bags
    End point description
    This analysis focuses on Electrolyte parameters of parenteral intakes (Safety Population). For the 3 treatment groups 300 mL, 500 mL, 1000 mL, the following are the mean body weight (grams) and mean total bag volume infused (mL/kg/day), respectively: 300 mL=1389 grams and 114.3 mL/kg/day; 500 mL= 3338 grams and 95.3 mL/kg/day); 1000 mL=31037 grams and 39.3 mL/kg/day. The following is the ESPEN-ESPGHAN recommended ranges for the following parameters by treatment group: 300 mL= Sodium: 0-5(up to 7) mmol/kg/day, Potassium: 0-5 mmol/kg/day, Magnesium: not provided, Calcium: 1-4 mmol/kg/day, Phosphate: 0.75-3 mmol/kg/day, Chloride: not provided; 500 mL= Sodium: 2-3 mmol/kg/day, Potassium: 1-3 mmol/kg/day, Magnesium: 0.1-0.2 mmol/kg/day, Calcium: 0.2-0.8 mmol/kg/day, Phosphate: 0.2-0.5 mmol/kg/day, Chloride: not provided; 1000 mL= Sodium: 1-3 mmol/kg/day, Potassium: 1-3 mmol/kg/day, Magnesium: 0.1 mmol/kg/day, Calcium: 0.2 mmol/kg/day, Phosphate: 0.2 mmol/kg/day, Chloride: not provided.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: mmol/kg/day
    arithmetic mean (standard deviation)
        Sodium
    2.46 ± 0.58
    2.24 ± 0.60
    1.82 ± 0.96
        Potassium
    2.39 ± 0.57
    2.24 ± 0.60
    1.29 ± 0.68
        Magnesium
    0.501 ± 0.121
    0.315 ± 0.084
    0.104 ± 0.057
        Calcium
    1.46 ± 0.35
    0.61 ± 0.16
    0.15 ± 0.08
        Phosphate
    1.45 ± 0.33
    0.84 ± 0.22
    0.39 ± 0.22
        Chloride
    3.58 ± 0.86
    2.76 ± 0.73
    1.74 ± 0.92
    No statistical analyses for this end point

    Secondary: Mean Daily Parenteral Intakes Including Additions

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    End point title
    		 Mean Daily Parenteral Intakes Including Additions
    End point description
    Safety population was used in this analysis. For the 3 treatment groups 300 mL, 500 mL, 1000 mL, the following are the mean body weight (grams) and mean total bag volume infused (mL/kg/day), respectively: 300 mL=1451 grams and 104 mL/kg/day; 500 mL= 3400 grams and 88 mL/kg/day); 1000 mL=31304 grams and 49.5 mL/kg/day. Also, the following is the ESPEN-ESPGHAN recommended ranges for the following parameters by treatment group: 300 mL bag=Total Bag volume infused:60-180 mL/kg/day, Amino acids:1.5-4 g/kg/day, Glucose:6-12 g/kg/day(up to 18), Lipids:1.25-3(up to 4) g/kg/day; 500 mL bag=Total Bag volume infused:80-150 mL/kg/day, Amino acids:1-2.5 g/kg/day, Glucose:8-16(up to 18) g/kg/day, Lipids:0.5-3(up to 4) g/kg/day; 1000 mL bag=Total Bag volume infused:50-100 mL/kg/day, Amino acids:1-2(up to 3) g/kg/day, Glucose:3-16 g/kg/day, Lipids:0.5-2(up to 3) g/kg/day.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: g/kg/d
    arithmetic mean (standard deviation)
        Nitrogen
    0.42 ± 0.11
    0.33 ± 0.09
    0.18 ± 0.07
        Amino acids
    2.84 ± 0.75
    2.26 ± 0.63
    1.16 ± 0.48
        Glucose
    12.20 ± 3.19
    13.71 ± 4.12
    9.94 ± 3.81
        Lipids
    2.17 ± 0.63
    2.24 ± 0.88
    1.26 ± 0.79
    No statistical analyses for this end point

    Secondary: Mean Daily Parenteral Intakes (Energy) Including Additions

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    End point title
    		 Mean Daily Parenteral Intakes (Energy) Including Additions
    End point description
    Safety population was used in this analysis. This analysis focuses on Energy parameters of parenteral intakes. For the 3 treatment groups 300 mL, 500 mL, 1000 mL, the following are the mean body weight (grams) and mean total bag volume infused (mL/kg/day), respectively: 300 mL=1451 grams and 104 mL/kg/day; 500 mL= 3400 grams and 88 mL/kg/day); 1000 mL=31304 grams and 49.5 mL/kg/day. Also, the following is the ESPEN-ESPGHAN recommended ranges for the Total Calories by treatment group: 300 mL: 100 -120 (calculated: 43-94; up to 128) kcal/kg/day, 500 mL: 90 -100 (calculated: 41-104; up to 122) kcal/kg/day, 1000 mL: 30 -90 (calculated: 21-90; up to 102) kcal/kg/day.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: kcal/kg/d
    arithmetic mean (standard deviation)
        Total parenteral energy
    81.9 ± 21.2
    86.3 ± 23.3
    57 ± 24.5
        Non-protein energy
    70.5 ± 18.2
    77.3 ± 21
    52.3 ± 22.6
        Glucose calories
    48.81 ± 12.76
    54.84 ± 16.48
    39.76 ± 15.26
        Lipid calories
    21.72 ± 6.27
    22.43 ± 8.83
    12.59 ± 7.91
        Lipid calories/non-protein calories
    30.6 ± 3.8
    28.9 ± 8.9
    21.6 ± 10.1
        Lipid calories/total calories
    26.4 ± 3.3
    26 ± 8.1
    19.9 ± 9.3
    No statistical analyses for this end point

    Secondary: Mean Daily Parenteral Intakes (Electrolytes) Including Additions

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    End point title
    		 Mean Daily Parenteral Intakes (Electrolytes) Including Additions
    End point description
    This analysis focuses on Energy parameters of parenteral intakes (Safety Population). For the 3 treatment groups 300 mL, 500 mL, 1000 mL, the following are the mean body weight (grams) and mean total bag volume infused (mL/kg/day), respectively: 300 mL=1451 grams and 104 mL/kg/day; 500 mL= 3400 grams and 88 mL/kg/day); 1000 mL=31304 grams and 49.5 mL/kg/day. The following is the ESPEN-ESPGHAN recommended ranges for the following parameters by treatment group: 300 mL= Sodium: 0-5(up to 7) mmol/kg/day, Potassium: 0-5 mmol/kg/day, Magnesium: not provided, Calcium: 1-4 mmol/kg/day, Phosphate: 0.75-3 mmol/kg/day, Chloride: not provided; 500 mL= Sodium: 2-3 mmol/kg/day, Potassium: 1-3 mmol/kg/day, Magnesium: 0.1-0.2 mmol/kg/day, Calcium: 0.2-0.8 mmol/kg/day, Phosphate: 0.2-0.5 mmol/kg/day, Chloride: not provided; 1000 mL= Sodium: 1-3 mmol/kg/day, Potassium: 1-3 mmol/kg/day, Magnesium: 0.1 mmol/kg/day, Calcium: 0.2 mmol/kg/day, Phosphate: 0.2 mmol/kg/day, Chloride: not provided.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: mmol/kg/d
    arithmetic mean (standard deviation)
        Sodium
    3.45 ± 2.21
    2.79 ± 1.26
    5.31 ± 6.71
        Potassium
    1.99 ± 0.60
    2.18 ± 0.71
    3.36 ± 5.19
        Magnesium
    0.391 ± 0.105
    0.279 ± 0.079
    0.152 ± 0.095
        Calcium
    1.18 ± 0.31
    0.60 ± 0.20
    0.23 ± 0.11
        Phosphate
    1.18 ± 0.41
    0.80 ± 0.27
    0.51 ± 0.23
        Chloride
    4.38 ± 2.23
    3.25 ± 1.26
    5.24 ± 5.38
    No statistical analyses for this end point

    Secondary: Body Weight Evolution (and Difference) between Baseline and End of Treatment

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    End point title
    		 Body Weight Evolution (and Difference) between Baseline and End of Treatment
    End point description
    Includes measure at each visit and the difference between visits. ITT population was used.
    End point type
    Secondary
    End point timeframe
    Day 0 (Baseline) to Day 5, or up to Day 10 (optional)
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    27
    18
    Units: Grams
    arithmetic mean (standard deviation)
        Baseline
    1373 ± 501
    3325 ± 1261
    31022 ± 14774
        End of Treatment
    1595 ± 523
    3483 ± 1232
    31560 ± 15041
        Difference between Baseline and End of Treatment
    221 ± 131
    163 ± 203
    538 ± 774
    No statistical analyses for this end point

    Secondary: Bag Ease of Use by Hospital Department and Overall

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    End point title
    		 Bag Ease of Use by Hospital Department and Overall
    End point description
    Two hospital departments (Pharmacy and Service) were given a questionnaire that required a "Yes" or "No" response for questions related to handling and ease of use. This data is displayed to show percentage of staff that answered "Yes." High percentages were desirable for all categories except for Premature Peel Seal Activation which would require a low percentage score since premature peeling is not desirable.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: Percentage of "yes" responses
    number (not applicable)
        Overpouch easy to open (Pharmacy)
    98.70
    75.86
    83.33
        Overpouch easy to open (Service)
    42.37
    73.91
    84.78
        Overpouch easy to open (Overall)
    70.17
    74.31
    84.38
        Bag easy to remove from overpouch (Pharmacy)
    98.48
    72.41
    94.44
        Bag easy to remove from overpouch (Service)
    44.28
    72.17
    88.04
        Bag easy to remove from overpouch (Overall)
    71.03
    72.22
    89.84
        Premature peel seal activation (Pharmacy)
    0
    0
    0
        Premature peel seal activation (Service)
    1.71
    1.74
    0
        Premature peel seal activation (Overall)
    0.86
    1.39
    0
        2-in-1: easy selective activation (Pharmacy)
    100
    100
    0
        2-in-1: easy selective activation (Service)
    81.25
    86.36
    65
        2-in-1: easy selective activation (Overall)
    93.18
    88.46
    65
        3-in-1: easy activation (Pharmacy)
    96.90
    76
    95
        3-in-1: easy activation (Service)
    80.22
    89.36
    90.41
        3-in-1: easy activation (Overall)
    88.22
    86.55
    92.04
        Quick homogeneity obtained (Pharmacy)
    98.91
    92.86
    97.50
        Quick homogeneity obtained (Service)
    90.73
    95.45
    97.85
        Quick homogeneity obtained (Overall)
    94.85
    94.93
    97.74
    No statistical analyses for this end point

    Secondary: Performance of Handling PED3CB bags versus Usual Practice measured by Mean Visual Analog Scale (VAS)

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    End point title
    		 Performance of Handling PED3CB bags versus Usual Practice measured by Mean Visual Analog Scale (VAS)
    End point description
    Hospital staff evaluated the performance of using PED3CB bags versus their usual practice. Responses were recorded on a form using a Visual Analog Scale (VAS) by ticking a 10-cm straight line. The ticks were converted in centimeters, measured from the left, where 0 cm is on the left and 10 cm on the right. Pictograms at both ends of this line indicated that ticking toward the left side would show a worse performance of the Ped3CB bag than their usual practice, and ticking toward the right side would show a better performance. The categories list the usual practice. The following abbreviations are used in describing usual practice: IB=Individual Bottles; WCB=Ward-Compounded Bags: RTU=RTU compounded bags; TP=Tailored Premixes; Rx=prescription.
    End point type
    Secondary
    End point timeframe
    Day 0 (Baseline) to Day 5
    End point values
    		 300 mL 500 mL 1000 mL
    Number of subjects analysed
    113
    28
    18
    Units: centimeters
    arithmetic mean (standard deviation)
        IB: bag manipulation (n=0,0,20)
    0 ± 0
    0 ± 0
    8 ± 1.3
        IB: Rx to infusion time (n=0,0,18)
    0 ± 0
    0 ± 0
    9 ± 0.8
        WCB: bag manipulation (n=460,29,45)
    8.1 ± 1.1
    7.6 ± 1.8
    8 ± 0.6
        WCB: Rx to infusion time (n=373,19,46)
    7.4 ± 1.6
    7.4 ± 1.6
    7.6 ± 0.7
        RTU: bag manipulation (n=241,58,40)
    6 ± 2.6
    7.5 ± 2
    7.1 ± 1.7
        RTU: Rx to infusion time (n=240,58,40)
    7.6 ± 1.9
    8.1 ± 1.7
    7.9 ± 1.2
        TP: bag manipulation (n=223,57,29)
    6.2 ± 2.2
    6.5 ± 2.1
    8.5 ± 0.9
        TP: Rx to infusion time (n=223,57,27)
    7 ± 1.7
    7 ± 2.1
    8.4 ± 0.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 (Baseline) through Day 5, or through Day 10 (optional for preterm newborn infants), with an additional 2 day follow-up period after the last infusion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11
    Reporting groups
    Reporting group title
    300 mL
    Reporting group description
    		 -

    Reporting group title
    500 mL
    Reporting group description
    		 -

    Reporting group title
    1000 mL
    Reporting group description
    		 -

    Serious adverse events
    		 300 mL 500 mL 1000 mL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 113 (3.54%)
    0 / 28 (0.00%)
    1 / 18 (5.56%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    Gastrointestinal disorders
    Gastrointestinal necrosis
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 28 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Emphysema
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Infections and infestations
    Herpes simplex
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Catheter sepsis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 28 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 300 mL 500 mL 1000 mL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 113 (68.14%)
    18 / 28 (64.29%)
    10 / 18 (55.56%)
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Hypotension
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Jaundice neonatal
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Catheter site erythema
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Catheter site inflammation
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Oedema
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    2
    1
    0
    Puncture site reaction
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 28 (7.14%)
    4 / 18 (22.22%)
         occurrences all number
    0
    2
    4
    Reproductive system and breast disorders
    Testicular disorder
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchopulmonary dysplasia
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Emphysema
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngeal oedema
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    2
    1
    0
    Lung disorder
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumothorax
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    3
    0
    0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Pulmonary oedema
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    3
    0
    0
    Respiratory acidosis
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    3
    0
    0
    Respiratory disorder
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory failure
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Tracheal obstruction
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Congenital, familial and genetic disorders
    Patent ductus arteriosus
         subjects affected / exposed
    7 / 113 (6.19%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    7
    0
    0
    Ventricular septal defect
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Cardiac failure
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Sedation
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 113 (9.73%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    12
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    3
    0
    0
    Eye disorders
    Abnormal sensation in eye
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 28 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    4 / 113 (3.54%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    4
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 28 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    7 / 113 (6.19%)
    0 / 28 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    8
    0
    2
    Diarrhoea
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Enteritis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Enterocolitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal necrosis
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 28 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Haematemesis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Necrotising colitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumoperitoneum
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Subileus
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 28 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    0
    4
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Petechiae
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 28 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Rash erythematous
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 28 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Anuria
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Azotaemia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Oliguria
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Renal failure
         subjects affected / exposed
    4 / 113 (3.54%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    4
    0
    0
    Infections and infestations
    Abdominal sepsis
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 28 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Candidiasis
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Candiduria
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Catheter sepsis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal infection
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Gastroenteritis astroviral
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes simplex
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes virus infection
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Nosocomial infection
         subjects affected / exposed
    5 / 113 (4.42%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    5
    0
    0
    Rhinitis
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    3
    0
    0
    Sepsis
         subjects affected / exposed
    9 / 113 (7.96%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    10
    0
    0
    Septic shock
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Staphylococcal sepsis
         subjects affected / exposed
    8 / 113 (7.08%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    8
    0
    0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    4 / 113 (3.54%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    4
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    12 / 113 (10.62%)
    2 / 28 (7.14%)
    0 / 18 (0.00%)
         occurrences all number
    13
    2
    0
    Hyperkalaemia
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 28 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    3
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Hypernatraemia
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    4 / 113 (3.54%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    4
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    8 / 113 (7.08%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    9
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    Hyponatraemia
         subjects affected / exposed
    9 / 113 (7.96%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    9
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    5 / 113 (4.42%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    5
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 28 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Sodium retention
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 28 (3.57%)
    0 / 18 (0.00%)
         occurrences all number
    2
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2008
    -Body weight to be collected on a daily basis. -pH measurement is not part of the usual department practices and will be replaced by bicarbonate measurement which is routinely collected in preterm newborn infants.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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