PREVENTING CHOLESTASIS IN PREMATURE INFANTS USING SMOFLIPID

Phase 1

Conditions: •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
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2011-005456-33-AT

Lead Sponsor: Med. Univ. Wien, Universitätsklinik für Kinder- und Jugendheilkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

•Infants born with a birth weight = 1000 Gram (= extreme low birth weight infants)
•Admission to the neonatal ward in the first 24 hours of life
•Informed consent obtained and randomized on study drug the first 5 days of life

Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Triplets or higher
•Conjugated bilirubin > 1.5 mg/dl before inclusion to the study
•Conditions associated with cholestasis independent of parenteral nutrition:
o Inborn errors of metabolism
o Viral Infections (cytomegaly virus, HIV, Hepatitis B, C)
o Immune mediated hemolytic diesease (e.g. Rhesus incompatibility)
o Cystic fibrosis
o Primary cholestatic diseases of the liver

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •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 ;Secondary Objective: •To assess the impact of SMOFLipid® on the long term neurocognitive development of extreme low birth weight infants at 12 and 24 months of corrected age ;Primary end point(s): ELBW infants are at high risk for development of parenteral nutrition associated cholestasis (PNAC). There is growing evidence for a positive effect of fish oil based intravenous lipid emulsions (ILE) for the treatment of PNAC. Primary use of a fish oil containing ILE for PN may prevent the development of PNAC. ;Timepoint(s) of evaluation of this end point: As long as parenteral nutrition is needed

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ELBW infants accumulate a deficit of ?3-LC-PUFA (especially DHA), which are important for neurodevelopment. An ILE containing fish oil provides these fatty acids and would reduce the deficit in ELBW infants, which may improve their neurocognitive development.;Timepoint(s) of evaluation of this end point: 12 to 24 month