EUCTR2011-005456-33-AT
Active, not recruiting
Phase 1
PREVENTING CHOLESTASIS IN PREMATURE INFANTS USING SMOFLIPID - Smoflipid
Med. Univ. Wien, Universitätsklinik für Kinder- und Jugendheilkunde0 sites200 target enrollmentJanuary 3, 2012
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 infantsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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
- Sponsor
- Med. Univ. Wien, Universitätsklinik für Kinder- und Jugendheilkunde
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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