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    Clinical Trial Results:
    A prospective, randomised, double-blind crossover study comparing 0.15 g/L rhBSSL added to pasteurized breast milk versus placebo during one week of treatment in preterm infants born before week 32 of gestational age

    Summary
    EudraCT number
    		 2007-002434-10
    Trial protocol
    		 FR   IT  
    Global end of trial date
    17 Feb 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2016
    First version publication date
    28 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BVT.BSSL-021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00659243
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Swedish Orphan Biovitrum
    Sponsor organisation address
    Tomtebodavägen 23, Stockholm, Sweden, 11276
    Public contact
    Medical Director, Swedish Orphan Biovitrum, 0046 86970000,
    Scientific contact
    Medical Director, Swedish Orphan Biovitrum, 0046 86970000,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000822-PIP01-09
    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
    17 Feb 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Feb 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the fat absorption (coefficient of fat absorption) in preterm infants following treatment with rhBSSL to that with placebo when administered in pasteurized breast milk.
    Protection of trial subjects
    The study was performed in accordance with the recommendations guiding physicians in biomedical research involving patients adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions ( ). The study was also conducted in accordance with the general principles of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) and European Union (EU) Directives 2001/20/EC and 2005/28/EC and under the ICH 11 Guidance for Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99). The recommendations of the Ad Hoc group for the development of guidelines for the implementing of Directive 2001/20/EC: Ethical Considerations for Clinical Trials Performed in Children was also considered.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Mar 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 27
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    32
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    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
    		 Preterm infants born before week 32 of gestation and who were ≤32weeks and 6 days of gestation (extrapolated age) at the time of first study dose, whose size was approprate for their gestational age, who were receiving pasteurized breast milk, and who were receiving enteral nutrition (bottle or nasal tube).

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 rhBSSL
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    rhBSSL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The amount of milk given was based on the patient’s body weight as recorded on the CRF each morning. The concentration of rhBSSL in pasteurized breast milk remained constant at 0.15 g/L. Patients received pasteurized breast milk with or without rhBSSL for 7 days depending on the randomization schedule. A matching amount of sterile water for injection (WFI) was added to the pasteurized breast milk without rhBSSL when the patient was assigned to placebo. The amount of milk given each day was recorded on the CRF. Infants were to receive approximately 150 to 180 mL milk/kg body weight per day. The feeding amount on a mL/kg basis for a particular infant was to remain constant for both treatment periods.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The amount of milk given was based on the patient’s body weight as recorded on the CRF each morning. Patients received pasteurized breast milk with or without rhBSSL for 7 days depending on the randomization schedule. A matching amount of sterile water for injection (WFI) was added to the pasteurized breast milk without rhBSSL when the patient was assigned to placebo. The amount of milk given each day was recorded on the CRF. Infants were to receive approximately 150 to 180 mL milk/kg body weight per day. The feeding amount on a mL/kg basis for a particular infant was to remain constant for both treatment periods.

    Number of subjects in period 1
    		rhBSSL Placebo
    Started
    29
    29
    Completed
    27
    28
    Not completed
    2
    1
         Adverse event, non-fatal
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 32 32
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 32 32
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Extrapolated gestational age at screening visit
    Units: weeks
        arithmetic mean (standard deviation)
    		 32.51 ± 0.535 -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 16 16
    Subject analysis sets

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who received at least one dose of randomized study medication (rhBSSL or placebo). The analysis of all safety and tolerability variables were performed using the safety analysis set.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients who received at least one dose of randomized study medication in both treatment periods.

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients included in FAS who had reasonable compliance and no other major protocol violations.

    Subject analysis set title
    rhBSSL - Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    rhBSSL - Per Protocol

    Subject analysis set title
    rhBSSL - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    rhBSSL - FAS

    Subject analysis set title
    Placebo - Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Placebo - Per Protocol

    Subject analysis set title
    Placebo - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo - FAS

    Subject analysis sets values
    		 Safety Analysis Set Full Analysis Set Per Protocol Set rhBSSL - Per Protocol rhBSSL - FAS Placebo - Per Protocol Placebo - FAS
    Number of subjects
    30
    27
    20
    20
    27
    20
    27
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    30
    27
    20
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Extrapolated gestational age at screening visit
    Units: weeks
        arithmetic mean (standard deviation)
    32.51 ± 0.535
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    rhBSSL
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who received at least one dose of randomized study medication (rhBSSL or placebo). The analysis of all safety and tolerability variables were performed using the safety analysis set.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients who received at least one dose of randomized study medication in both treatment periods.

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients included in FAS who had reasonable compliance and no other major protocol violations.

    Subject analysis set title
    rhBSSL - Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    rhBSSL - Per Protocol

    Subject analysis set title
    rhBSSL - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    rhBSSL - FAS

    Subject analysis set title
    Placebo - Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Placebo - Per Protocol

    Subject analysis set title
    Placebo - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo - FAS

    Primary: Coefficient of fat absorption (CFA) measured in stool collected for a 72 hour period during the final 3 days of each treatment period.

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    End point title
    		 Coefficient of fat absorption (CFA) measured in stool collected for a 72 hour period during the final 3 days of each treatment period.
    End point description
    End point type
    Primary
    End point timeframe
    The collection of feces for the determination of coefficient of fat absorption (CFA) was performed over a period corresponding to the fat (formula) ingestion during 72 hours toward the end of each treatment.
    End point values
    		 rhBSSL - Per Protocol Placebo - Per Protocol
    Number of subjects analysed
    20
    20
    Units: percentage
        arithmetic mean (standard deviation)
    68.46 ± 15.333
    63.82 ± 17.875
    Statistical analysis title
    		 ANOVA CFA
    Statistical analysis description
    The primary efficacy outcome, CFA from the last three days of each treatment period, will be analyzed by an analysis of variance (ANOVA) with treatment, period, and sequence as factors with patient as a random effect nested within sequence.
    Comparison groups
    rhBSSL - Per Protocol v Placebo - Per Protocol
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.073
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    4.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 10.22
    Notes
    [1] - Please note that this is a crossover study and each subject receives both treatments in a randomized order. The number of subjects stated below does not account for the crossover design and is therefore stated as twice as high as the correct number of patients.

    Secondary: Change in body weight (g/kg/day) between the start and end of each treatment period - Per Protocol

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    End point title
    		 Change in body weight (g/kg/day) between the start and end of each treatment period - Per Protocol
    End point description
    End point type
    Secondary
    End point timeframe
    The patient’s weight in grams (g) was recorded each day and entered on the CRF. To the extent possible, body weight was measured at approximately the same time each day using a scale with an accuracy of at least ±5 g.
    End point values
    		 rhBSSL - Per Protocol Placebo - Per Protocol
    Number of subjects analysed
    20
    20
    Units: g/kg/day
        arithmetic mean (standard deviation)
    16.16 ± 4.856
    14.59 ± 4.63
    Statistical analysis title
    		 Change in body weight - Per Protocol
    Statistical analysis description
    The secondary efficacy outcomes will be analyzed by an analysis of variance (ANOVA) with treatment, period, and sequence as factors with patient as a random effect nested within sequence.
    Comparison groups
    rhBSSL - Per Protocol v Placebo - Per Protocol
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.271
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.46
         upper limit
    		 4.88
    Notes
    [2] - Please note that this is a crossover study and each subject receives both treatments in a randomized order. The number of subjects stated below does not account for the crossover design and is therefore stated as twice as high as the correct number of patients.

    Secondary: Change in body weight (g/kg/day) between the start and end of each treatment period - FAS

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    End point title
    		 Change in body weight (g/kg/day) between the start and end of each treatment period - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    First measurement done at Screening Visit (Day -7 to -1) and thereafter daily on Day 1 to Day 17 and at Follow up visit (Day 20-26).
    End point values
    		 rhBSSL - FAS Placebo - FAS
    Number of subjects analysed
    27
    27
    Units: g/kg/day
        arithmetic mean (standard deviation)
    15.54 ± 4.88
    13.63 ± 5.292
    Statistical analysis title
    		 Change in body weight - FAS
    Statistical analysis description
    The secondary efficacy outcomes will be analyzed by an analysis of variance (ANOVA) with treatment, period, and sequence as factors with patient as a random effect nested within sequence.
    Comparison groups
    Placebo - FAS v rhBSSL - FAS
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.119
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 4.43
    Notes
    [3] - Please note that this is a crossover study and each subject receives both treatments in a randomized order. The number of subjects stated below does not account for the crossover design and is therefore stated as twice as high as the correct number of patients.

    Secondary: Change in length from knee-to-heel (mm) between the start and end of each treatment period - Per Protocol

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    End point title
    		 Change in length from knee-to-heel (mm) between the start and end of each treatment period - Per Protocol
    End point description
    End point type
    Secondary
    End point timeframe
    First measurement done at Screening Visit (Day -7 to -1) and thereafter daily on Day 1 to Day 17 and at Follow up visit (Day 20-26). To the extent possible, length was measured at approximately the same time each day.
    End point values
    		 rhBSSL - Per Protocol Placebo - Per Protocol
    Number of subjects analysed
    20
    20
    Units: mm
        arithmetic mean (standard deviation)
    2.43 ± 1.621
    1.83 ± 3.032
    Statistical analysis title
    		 Change of Knee-to heel Length in PP population
    Statistical analysis description
    The secondary efficacy outcomes will be analyzed by an analysis of variance (ANOVA) with treatment, period, and sequence as factors with patient as a random effect nested within sequence.
    Comparison groups
    rhBSSL - Per Protocol v Placebo - Per Protocol
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.361
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 1.65
    Notes
    [4] - Please note that this is a crossover study and each subject receives both treatments in a randomized order. The number of subjects stated below does not account for the crossover design and is therefore stated as twice as high as the correct number of patients.

    Secondary: Change in length from knee-to-heel (mm) between the start and end of each treatment period - FAS

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    End point title
    		 Change in length from knee-to-heel (mm) between the start and end of each treatment period - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    First measurement done at Screening Visit (Day -7 to -1) and thereafter daily on Day 1 to Day 17 and at Follow up visit (Day 20-26) To the extent possible, length was measured at approximately the same time each day.
    End point values
    		 rhBSSL - FAS Placebo - FAS
    Number of subjects analysed
    27
    27
    Units: mm
        arithmetic mean (standard deviation)
    2.17 ± 1.95
    1.7 ± 2.796
    Statistical analysis title
    		 Change of Knee-to heel Length in FAS population
    Statistical analysis description
    The secondary efficacy outcomes will be analyzed by an analysis of variance (ANOVA) with treatment, period, and sequence as factors with patient as a random effect nested within sequence.
    Comparison groups
    rhBSSL - FAS v Placebo - FAS
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.376
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 1.34
    Notes
    [5] - Please note that this is a crossover study and each subject receives both treatments in a randomized order. The number of subjects stated below does not account for the crossover design and is therefore stated as twice as high as the correct number of patients.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The AE reporting period for this study began upon administration of the first dose of investigational medication (Baseline visit) and ended 1 week ± 3 days after last dose of study drug intake (follow-up visit).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    rhBSSL
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 rhBSSL Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 rhBSSL Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 28 (57.14%)
    14 / 29 (48.28%)
    Investigations
    Cardiac murmur
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    4
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 29 (10.34%)
         occurrences all number
    2
    13
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    Anaemia neonatal
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Thrombocythaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Application site discolouration
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Oedema
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Retinopathy of prematurity
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Anal fissure
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Colitis ulcerative
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Haematochezia
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1
    Necrotising colitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Regurgitation
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    9 / 28 (32.14%)
    8 / 29 (27.59%)
         occurrences all number
    15
    10
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Renal tubular acidosis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Infections and infestations
    Fungal infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Sepsis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Viral infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 29 (6.90%)
         occurrences all number
    3
    2
    Hyponatraemia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Metabolic acidosis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2009
    • Changed enrollment age requirement from ≤32 weeks and 6 days of gestation at the time of enrollment to ≤32 weeks and 6 days of gestation at the time of first study drug dose • Added exploratory analysis of long-chain polyunsaturated fatty acids measure in stool collected • Changed sample processing where complete diapers were to be sent to the central laboratory
    01 Jun 2009
    • Harmonised the unit for the secondary efficacy variable change in body weight as gram per kg per day across all sections of the protocol • Added a statistical hypothesis of change in body weight as part of the confirmatory strategy • Pre-defined that a statistical analysis with respect to the change in body weight and CFA was performed using combined data from this study and study BVT.BSSL 020 • Added the definition of change in body weight • Harmonized the text in the statistical analysis section with earlier sections of the protocol.

    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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