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

    Summary
    EudraCT number
    		 2007-002423-33
    Trial protocol
    		 IT  
    Global end of trial date
    10 May 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BVT.BSSL-020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00658905
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Swedish Orphan Biovitrum AB
    Sponsor organisation address
    Tomtebodavägen 23, Stockholm, Sweden, 11276
    Public contact
    Medical Director, Swedish Orphan Biovitrum AB, 0046 86970000,
    Scientific contact
    Medical Director, Swedish Orphan Biovitrum AB, 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
    10 May 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2009
    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 infant formula.
    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
    26 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
    Italy: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    33
    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 ≤32 weeks and 6 days of gestation (extrapolated age) at the time of first study dose, whose size was appropriate for their gestational age, who were receiving infant formula, 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
    rhBSSL, liquid solution 0.15 g/L according to body weight. Infants were to receive approximately 150 to 180 mL formula/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. The amount of formula given was based on the patient’s body weight as recorded on the CRF each morning. The concentration of rhBSSL in the formula remained constant at 0.15 g/L. Patients received formula 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 formula without rhBSSL when the patient was assigned to placebo. The amount of formula given each day was recorded on the CRF.

    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
    Placebo - Sterile water for injection, liquid solution, volume to match rhBSSL according to body weight. Infants were to receive approximately 150 to 180 mL formula/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. The amount of formula given was based on the patient’s body weight as recorded on the CRF each morning. Patients received formula without rhBSSL for 7 days depending on the randomization schedule. A matching amount of sterile water for injection (WFI) was added to the formula without rhBSSL when the patient was assigned to placebo. The amount of formula given each day was recorded on the CRF.

    Number of subjects in period 1
    		rhBSSL Placebo
    Started
    33
    33
    Completed
    33
    32
    Not completed
    0
    1
         Adverse event, serious fatal
    -
    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
    		 33 33
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 33 33
        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
        least squares mean (standard deviation)
    		 32.45 ± 0.463 -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 17 17
    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 (FAS)
    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 Analysis Set (PP)
    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. The assessment of patients who qualified for the PP analysis set was performed prior to database lock and unblinding of the study. For analyses of the primary efficacy variable using the PP analysis set, only patients with valid CFA measurements from both treatment periods were included.

    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 (FAS) Per-protocol Analysis Set (PP) rhBSSL - Per Protocol rhBSSL - FAS Placebo - Per Protocol Placebo - FAS
    Number of subjects
    33
    33
    26
    26
    33
    26
    33
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    33
    33
    26
    26
    33
    26
    33
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    0
    0
    0
    Age continuous
    Extrapolated gestational age at screening visit
    Units: weeks
        least squares mean (standard deviation)
    32.45 ± 0.463
    32.45 ± 0.463
    ±
    ±
    32.45 ± 0.463
    ±
    32.45 ± 0.463
    Gender categorical
    Units: Subjects
        Female
    16
    16
    12
        Male
    17
    17
    14

    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 (FAS)
    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 Analysis Set (PP)
    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. The assessment of patients who qualified for the PP analysis set was performed prior to database lock and unblinding of the study. For analyses of the primary efficacy variable using the PP analysis set, only patients with valid CFA measurements from both treatment periods were included.

    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 - Per Protocol Set

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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 - Per Protocol Set
    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 period.
    End point values
    		 rhBSSL - Per Protocol Placebo - Per Protocol
    Number of subjects analysed
    26
    26
    Units: percentage
        arithmetic mean (standard deviation)
    69.55 ± 14.452
    67.07 ± 14.849
    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
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.462
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    2.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.67
         upper limit
    		 7.84
    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 length from knee-to-heel (mm) between the start and end of each treatment period -Per Protocol Set

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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 Set
    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
    22
    22
    Units: mm
        arithmetic mean (standard deviation)
    2.63 ± 1.014
    2.82 ± 2.575
    Statistical analysis title
    		 Change in length from knee-to-heel - 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
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.558
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 0.84
    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 - Per Protocol Set

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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 Set
    End point description
    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 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 - Per Protocol Placebo - Per Protocol
    Number of subjects analysed
    26
    26
    Units: g/kg/day
        arithmetic mean (standard deviation)
    17.79 ± 4.013
    15.39 ± 5.412
    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
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.038
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 4.47
    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 -Full Analysis Set

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    End point title
    		 Change in length from knee-to-heel (mm) between the start and end of each treatment period -Full Analysis Set
    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
    28
    28
    Units: mm
        arithmetic mean (standard deviation)
    2.91 ± 1.366
    2.84 ± 2.36
    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
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.67
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 0.84
    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 body weight (g/kg/day) between the start and end of each treatment period - Full Analysis Set

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    End point title
    		 Change in body weight (g/kg/day) between the start and end of each treatment period - Full Analysis Set
    End point description
    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 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
    33
    33
    Units: mm
        arithmetic mean (standard deviation)
    18.06 ± 3.964
    14.29 ± 6.493
    Statistical analysis title
    		 change in 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
    rhBSSL - FAS v Placebo - FAS
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    3.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.58
         upper limit
    		 5.9
    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 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 / 33 (0.00%)
    1 / 33 (3.03%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Meningitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    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
    13 / 33 (39.39%)
    17 / 33 (51.52%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Bronchospasm
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Pneumonitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Investigations
    Cardiac murmur
         subjects affected / exposed
    3 / 33 (9.09%)
    2 / 33 (6.06%)
         occurrences all number
    3
    2
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Tachycardia
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 33 (9.09%)
         occurrences all number
    1
    3
    Anaemia neonatal
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Thrombocythaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Retinopathy of prematurity
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    4 / 33 (12.12%)
    5 / 33 (15.15%)
         occurrences all number
    5
    5
    Rash
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Sepsis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 33 (6.06%)
         occurrences all number
    1
    2
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Metabolic acidosis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1

    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 • Added collection of feces from 1–2 preterm infants to perform validation of method of analysis at the laboratory.
    10 May 2009
    Amendment Date: 01-Jun-2009 • Harmonized 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 021 • 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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