N/A
N=80
The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities
Retinopathy of Prematurity · Neonatal Cholestasis
Bottom Line
View on ClinicalTrials.gov: NCT01875510 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Number of Participants With Retinopathy of Prematurity — 2; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fish-oil emulsions (Dietary_supplement); soybean-oil emulsion (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Dr. Sami Ulus Children's Hospital
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Retinopathy of Prematurity |
2; 13 | — |
Summary
Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal development. Infants born prematurely are at special risk for DHA insufficiency. The source of DHA after birth for preterm babies who are not fed full enterally, are mostly fat emulsions as the component of total parenteral nutrition solutions which usually do not contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered from the first day of life and during parenteral nutrition-prevents infants from cholestasis and retinopathy of prematurity.
Eligibility Criteria
Inclusion Criteria
- Infants below 32 gestational age and requiring parenteral nutrition
Exclusion Criteria
- Infants with congenital anomalies, infants above 32 gestational age
Data sourced from ClinicalTrials.gov (NCT01875510). 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.