Phase 3
N=44
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
Cholestasis
Bottom Line
View on ClinicalTrials.gov: NCT02663453 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Incidence of Neonatal Cholestasis — 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- multicomponent lipid emulsion (Drug); pure soybean oil lipid emulsion (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Thammasat University
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Neonatal Cholestasis |
1; 2 | — |
| SECONDARY Neonatal Morbidities |
7; 6; 10; 9 | — |
| SECONDARY Incidence of Extrauterine Growth Restriction (EUGR) |
8; 12 | — |
| SECONDARY Weight Gain |
19.7; 18.8 | — |
| SECONDARY Height Gain |
0.9; 0.8 | — |
| SECONDARY Head Circumference Gain |
0.7; 0.7 | — |
| SECONDARY Assessment of Gamma Glutamyltranspeptidase (GGT) |
134.7; 138.7; 73.8; 79.5; 63.1; 68.6 | — |
| SECONDARY Assessment of Alanine Aminotransferase (ALT) |
16.3; 15.1; 14.7; 15.1; 17.1; 19.8 | — |
| SECONDARY Assessment of Aspartate Aminotransferase (AST) |
61.8; 55.6; 26.5; 26.0; 26.2; 24.4 | — |
Summary
The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis, infant growth, infant morbidity and the biochemical assessment of liver enzymes.
Eligibility Criteria
Inclusion Criteria
- Inborn infants with a gestational age of less than 30 weeks
- Who required parenteral nutrition for at least 7 days
Exclusion Criteria
- Evidence of congenital infection
- Perinatal asphyxia
- Congenital anomalies
- Severe IVH
- Thrombocytopenia
- Shock or circulation failure
- Renal or hepatic disorders.
Data sourced from ClinicalTrials.gov (NCT02663453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.