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    Clinical Trial Results:
    PREVENTING CHOLESTASIS IN PREMATURE INFANTS USING SMOFLIPID

    Summary
    EudraCT number
    		 2011-005456-33
    Trial protocol
    		 AT  
    Global end of trial date
    17 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Apr 2018
    First version publication date
    29 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    v 1.3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01585935
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Dr. Repa, Medical University Vienna, andreas.repa@meduniwien.ac.at
    Scientific contact
    Dr. Repa, Medical University Vienna, andreas.repa@meduniwien.ac.at
    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
    13 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare a mixed parenteral lipid emulsion containing fish oil (SMOFlipid®) with a soybean oil based lipid emulsion (Intralipid®) for its effect on the occurrence of parenteral nutrition associated cholestasis in extremely low birth weight infants.
    Protection of trial subjects
    Only routine blood samples and testing was used.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 230
    Worldwide total number of subjects
    230
    EEA total number of subjects
    230
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    230
    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
    		 This double-blind randomized trial of 230 ELBW infants was recruiting from June 2012 to July 2015 in a single center in Vienna, Austria.

    Pre-assignment
    Screening details
    		 Eligible participants were preterm Infants born below 1 kg and admitted before 24 hours of life. Infants with cholestasis (conjugated bilirubin >1.5 mg/dL [25 µmol/L]) before intervention and higher order multiples were not eligible. Infants with conditions associated with cholestasis independent of parenteral nutrition were excluded.

    Pre-assignment period milestones
    Number of subjects started
    		 230
    Number of subjects completed
    		 230

    Period 1
    Period 1 title
    Active treatment (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
    Blinding implementation details
    The investigational products were visually indistinguishable white fluids. The glass containers were masked using opaque labels designated “A” or “B.” Labels were resistant to detachment and discarded containers were controlled for blinding integrity.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SMOF
    Arm description
    		 Infants received the mixed lipid emulsion (SMOFlipid)
    Arm type
    		 Experimental

    Investigational medicinal product name
    SMOFlipid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for suspension for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    1-3 g /kg/d continous over 24 hours

    Arm title
    		 Intralipid
    Arm description
    		 Patients received the soybean oil based livid emulsion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Intralipid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    1-3 g /kg/d continous over 24 hours

    Number of subjects in period 1
    		SMOF Intralipid
    Started
    113
    117
    Completed
    113
    117

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SMOF
    Reporting group description
    		 Infants received the mixed lipid emulsion (SMOFlipid)

    Reporting group title
    Intralipid
    Reporting group description
    		 Patients received the soybean oil based livid emulsion

    Reporting group values
    		 SMOF Intralipid Total
    Number of subjects
    		 113 117 230
    Age categorical
    Infants are preterm infants born below 1 kg birth weight
    Units: Subjects
        Preterm newborn infants (gestational age < 37 wks)
    		 113 117 230
    Gender categorical
    Units: Subjects
        Female
    		 49 44 93
        Male
    		 64 73 137

    End points

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    End points reporting groups
    Reporting group title
    SMOF
    Reporting group description
    		 Infants received the mixed lipid emulsion (SMOFlipid)

    Reporting group title
    Intralipid
    Reporting group description
    		 Patients received the soybean oil based livid emulsion

    Primary: Cholestasis

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    End point title
    		 Cholestasis
    End point description
    End point type
    Primary
    End point timeframe
    Birth to discharge from hospital
    End point values
    		 SMOF Intralipid
    Number of subjects analysed
    110
    113
    Units: Subjects
    11
    18
    Statistical analysis title
    		 Univariate Analysis
    Comparison groups
    SMOF v Intralipid
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From allocation to discharge from hospital
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    SMOF
    Reporting group description
    		 Infants received the mixed lipid emulsion (SMOFlipid)

    Reporting group title
    Intralipid
    Reporting group description
    		 Patients received the soybean oil based livid emulsion

    Serious adverse events
    		 SMOF Intralipid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 110 (27.27%)
    21 / 113 (18.58%)
         number of deaths (all causes)
    8
    8
         number of deaths resulting from adverse events
    1
    0
    Nervous system disorders
    Intraventricular haemorrhage neonatal
    Additional description: Severe Grade 3/4
         subjects affected / exposed
    12 / 110 (10.91%)
    9 / 113 (7.96%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinopathy of prematurity
    Additional description: Severe retinopathy of prematurity requiring treatment
         subjects affected / exposed
    9 / 110 (8.18%)
    10 / 113 (8.85%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Necrotising enterocolitis neonatal
         subjects affected / exposed
    8 / 110 (7.27%)
    8 / 113 (7.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SMOF Intralipid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    110 / 110 (100.00%)
    113 / 113 (100.00%)
    Cardiac disorders
    Persistent foetal circulation
    Additional description: PDA requiring treatment
         subjects affected / exposed
    56 / 110 (50.91%)
    68 / 113 (60.18%)
         occurrences all number
    56
    68
    Bradycardia neonatal
         subjects affected / exposed
    110 / 110 (100.00%)
    113 / 113 (100.00%)
         occurrences all number
    110
    113
    Respiratory, thoracic and mediastinal disorders
    Bronchopulmonary dysplasia
    Additional description: Oxygen need after 36 weeks PMA
         subjects affected / exposed
    19 / 110 (17.27%)
    21 / 113 (18.58%)
         occurrences all number
    19
    21
    Pulmonary hypertension
         subjects affected / exposed
    23 / 110 (20.91%)
    31 / 113 (27.43%)
         occurrences all number
    23
    31
    Infections and infestations
    Sepsis
    Additional description: Blood culture positive sepsis
         subjects affected / exposed
    24 / 110 (21.82%)
    26 / 113 (23.01%)
         occurrences all number
    24
    26
    Metabolism and nutrition disorders
    Hyperlipidaemia
    Additional description: Trigylcerides > 250 mg/dl
         subjects affected / exposed
    39 / 110 (35.45%)
    38 / 113 (33.63%)
         occurrences all number
    39
    38

    More information

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    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29269199
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