Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35321   clinical trials with a EudraCT protocol, of which   5780   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age

    Summary
    EudraCT number
    2014-005032-34
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    06 Oct 2006

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    MK-0991-058
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00330395
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000010-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    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
    06 Oct 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate plasma concentrations of caspofungin at 1 hour (peak) and 24 hours (trough) after administration of caspofungin 25 mg/m^2 intravenous (IV) to neonates and infants <3 months of age. Safety and tolerability of caspofungin will also be evaluated.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    Amphotericin B deoxycholate or a lipid preparation of amphotericin was administered on each day caspofungin was administered. Notably, amphotericin therapy could continue to be administered at the investigator's discretion after caspofungin therapy had ended. After the last day of caspofungin therapy, any additional use of an IV amphotericin B formulation was considered as part of the follow-up period for this study. If the participant was discontinued from IV amphotericin B therapy and not placed on another form of amphotericin or was placed on an azole preparation, the caspofungin therapy was also discontinued.
    Evidence for comparator
    -
    Actual start date of recruitment
    24 May 2006
    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
    Mexico: 4
    Country: Number of subjects enrolled
    Colombia: 3
    Country: Number of subjects enrolled
    Panama: 5
    Country: Number of subjects enrolled
    India: 4
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    18
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    8
    Infants and toddlers (28 days-23 months)
    10
    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

    Close Top of page
    Recruitment
    Recruitment details
    The two panels of participants were enrolled sequentially, Panel A followed by Panel B.

    Pre-assignment
    Screening details
    A total of 21 participants were screened and 18 participants were enrolled.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Panel A: Caspofungin Single Dose on Day 1
    Arm description
    Participants received caspofungin 25 mg/m^2 in a 1-hour intravenous infusion on Day 1, followed by a 14-day follow-up period.
    Arm type
    Experimental

    Investigational medicinal product name
    Caspofungin
    Investigational medicinal product code
    Other name
    CANCIDAS™, MK-0991
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Caspofungin acetate 25 mg/m^2 in a 1-hour intravenous infusion on Day 1. Infusion employed a pediatric syringe or ambulatory pump.

    Arm title
    Panel B: Caspofungin Daily for 4 to 28 days
    Arm description
    Participants received caspofungin 25 mg/m^2/day in a 1-hour intravenous infusion for a minimum of 4 days and a maximum of 28 days, followed by a 14-day follow-up period.
    Arm type
    Experimental

    Investigational medicinal product name
    Caspofungin
    Investigational medicinal product code
    Other name
    CANCIDAS™, MK-0991
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Caspofungin acetate 25 mg/m^2/day in a 1-hour intravenous infusion for a minimum of 4 days and a maximum of 28 days. Infusion employed a pediatric syringe or ambulatory pump.

    Number of subjects in period 1
    Panel A: Caspofungin Single Dose on Day 1 Panel B: Caspofungin Daily for 4 to 28 days
    Started
    6
    12
    Completed study therapy
    6
    11
    Completed
    4
    11
    Not completed
    2
    1
         Adverse event, serious fatal
             2
             1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Panel A: Caspofungin Single Dose on Day 1
    Reporting group description
    Participants received caspofungin 25 mg/m^2 in a 1-hour intravenous infusion on Day 1, followed by a 14-day follow-up period.

    Reporting group title
    Panel B: Caspofungin Daily for 4 to 28 days
    Reporting group description
    Participants received caspofungin 25 mg/m^2/day in a 1-hour intravenous infusion for a minimum of 4 days and a maximum of 28 days, followed by a 14-day follow-up period.

    Reporting group values
    Panel A: Caspofungin Single Dose on Day 1 Panel B: Caspofungin Daily for 4 to 28 days Total
    Number of subjects
    6 12 18
    Age categorical
    Units: Subjects
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    3.8 ± 2.5 4.9 ± 3.2 -
    Gender categorical
    Units: Subjects
        Female
    3 3 6
        Male
    3 9 12

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Panel A: Caspofungin Single Dose on Day 1
    Reporting group description
    Participants received caspofungin 25 mg/m^2 in a 1-hour intravenous infusion on Day 1, followed by a 14-day follow-up period.

    Reporting group title
    Panel B: Caspofungin Daily for 4 to 28 days
    Reporting group description
    Participants received caspofungin 25 mg/m^2/day in a 1-hour intravenous infusion for a minimum of 4 days and a maximum of 28 days, followed by a 14-day follow-up period.

    Subject analysis set title
    Panel A + Panel B
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants in both panels received caspofungin 25 mg/m^2 in a 1-hour intravenous infusion on Day 1. Participants in Panel B continued to receive caspofungin 25 mg/m^2/day for a minimum of 4 days and a maximum of 28 days. For both panels, the last dose of caspofungin was followed by a 14-day follow-up period.

    Primary: Plasma Concentration of Caspofungin at 24 Hours (C24hr) on Day 1

    Close Top of page
    End point title
    Plasma Concentration of Caspofungin at 24 Hours (C24hr) on Day 1 [1]
    End point description
    Plasma caspofungin concentrations were measured with a high-performance liquid chromatography method.
    End point type
    Primary
    End point timeframe
    Plasma samples for measurement of caspofungin concentrations were collected on Day 1 before dosing and at 1 and 24 hours after initiation of the 1-hour infusion.
    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: Results are displayed for Panels A and B combined; therefore, no statistical analyses were performed for this endpoint.
    End point values
    Panel A + Panel B
    Number of subjects analysed
    18
    Units: μg/mL
        least squares mean (confidence interval 95%)
    1.8 (1.4 to 2.4)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Caspofungin at One Hour (C1hr) on Day 1

    Close Top of page
    End point title
    Plasma Concentration of Caspofungin at One Hour (C1hr) on Day 1
    End point description
    Plasma caspofungin concentrations were measured with a high-performance liquid chromatography method.
    End point type
    Secondary
    End point timeframe
    Plasma samples for measurement of caspofungin concentrations were collected on Day 1 before dosing and at 1 and 24 hours after initiation of the 1-hour infusion.
    End point values
    Panel A + Panel B
    Number of subjects analysed
    18
    Units: μg/mL
        least squares mean (confidence interval 95%)
    8.2 (6.8 to 10)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Caspofungin at One Hour (C1hr) on Day 4

    Close Top of page
    End point title
    Plasma Concentration of Caspofungin at One Hour (C1hr) on Day 4 [2]
    End point description
    Plasma caspofungin concentrations were measured with a high-performance liquid chromatography method.
    End point type
    Secondary
    End point timeframe
    Plasma samples for measurement of caspofungin concentrations were collected on Day 4 before dosing and at 1 and 24 hours after initiation of the 1-hour infusion.
    Notes
    [2] - 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: This endpoint evaluated pharmacokinetics on Day 4. Panel A only collected samples for Day 1 and is not applicable to this endpoint. Therefore only Panel B, which collected samples for Day 4, was evaluated for this endpoint.
    End point values
    Panel B: Caspofungin Daily for 4 to 28 days
    Number of subjects analysed
    12
    Units: μg/mL
        least squares mean (confidence interval 95%)
    11.1 (8.8 to 13.9)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Caspofungin at 24 Hours (C24hr) on Day 4

    Close Top of page
    End point title
    Plasma Concentration of Caspofungin at 24 Hours (C24hr) on Day 4 [3]
    End point description
    Plasma caspofungin concentrations were measured with a high-performance liquid chromatography method.
    End point type
    Secondary
    End point timeframe
    Plasma samples for measurement of caspofungin concentrations were collected on Day 4 before dosing and at 1 and 24 hours after initiation of the 1-hour infusion.
    Notes
    [3] - 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: This endpoint evaluated pharmacokinetics on Day 4. Panel A only collected samples for Day 1 and is not applicable to this endpoint. Therefore only Panel B, which collected samples for Day 4, was evaluated for this endpoint.
    End point values
    Panel B: Caspofungin Daily for 4 to 28 days
    Number of subjects analysed
    11
    Units: μg/mL
        least squares mean (confidence interval 95%)
    2.4 (1.8 to 3.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with One or More Adverse Events

    Close Top of page
    End point title
    Percentage of Participants with One or More Adverse Events
    End point description
    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product, is also an adverse experience.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after the last dose of study drug.
    End point values
    Panel A: Caspofungin Single Dose on Day 1 Panel B: Caspofungin Daily for 4 to 28 days
    Number of subjects analysed
    6
    12
    Units: Percentage of participants
    number (not applicable)
        Clinical Adverse Events
    100
    91.7
        Laboratory Adverse Events
    0
    66.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants Discontinued Due to an Adverse Event

    Close Top of page
    End point title
    Percentage of Participants Discontinued Due to an Adverse Event
    End point description
    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product, is also an adverse experience.
    End point type
    Secondary
    End point timeframe
    Up to completion of the last infusion of study drug (Panel A: Day 1; Panel B: up to Day 28)
    End point values
    Panel A: Caspofungin Single Dose on Day 1 Panel B: Caspofungin Daily for 4 to 28 days
    Number of subjects analysed
    6
    12
    Units: Percentage of participants
    number (not applicable)
        Clinical Adverse Event
    0
    8.3
        Laboratory Adverse Event
    0
    0
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 14 days after the last dose of study drug
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Panel A: Caspofungin Single Dose on Day 1
    Reporting group description
    Participants received caspofungin 25 mg/m^2 in a 1-hour intravenous infusion on Day 1, followed by a 14-day follow-up period.

    Reporting group title
    Panel B: Caspofungin Daily for 4 to 28 days
    Reporting group description
    Participants received caspofungin 25 mg/m^2/day in a 1-hour intravenous infusion for a minimum of 4 days and a maximum of 28 days, followed by a 14-day follow-up period.

    Serious adverse events
    Panel A: Caspofungin Single Dose on Day 1 Panel B: Caspofungin Daily for 4 to 28 days
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    3 / 12 (25.00%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Congenital, familial and genetic disorders
    Patent ductus arteriosus
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Hypoxic encephalopathy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal perforation
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal stenosis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising colitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Bacterial sepsis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter sepsis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fungal endocarditis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Panel A: Caspofungin Single Dose on Day 1 Panel B: Caspofungin Daily for 4 to 28 days
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    11 / 12 (91.67%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 12 (16.67%)
         occurrences all number
    1
    6
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Band neutrophil count increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Bilirubin conjugated increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    6
    Blood bilirubin increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    4
    Blood creatinine increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    6
    Blood potassium decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Blood potassium increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    4
    Blood urea increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    C-reactive protein increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    5
    Haematocrit decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Haemoglobin decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    4
    Neutrophil count increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    3
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    Platelet count decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    White blood cell count increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    3
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Sinus tachycardia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    6
    Respiratory, thoracic and mediastinal disorders
    Apnoeic attack
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Bronchopulmonary dysplasia
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Chronic respiratory disease
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Hyperventilation
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    11
    Pulmonary congestion
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Respiratory distress
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Anaemia neonatal
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Cerebral atrophy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Eye disorders
    Retinopathy of prematurity
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Hypothermia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    9
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Anal fissure
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Perianal erythema
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Malnutrition
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Infections and infestations
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Enterobacter sepsis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Sepsis neonatal
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA