N/A
N=30
PUFA Supplementation in Premature Infants
Premature, Extremely Low Birth Weight Infants · Polyunsaturated Fatty Acid Levels
Bottom Line
View on ClinicalTrials.gov: NCT01955044 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Mar 2016
Primary outcome: Primary: Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels — 4.45; 4.02; 5.27; 20.3 weight % (g/100g)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LCPUFA supplement (Dietary_supplement); placebo (Dietary_supplement)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Endeavor Health
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels |
4.45; 4.02; 5.27; 20.3; 19.3; 21.58 | — |
| SECONDARY LCPUFA Levels |
5.52; 5.58; 6.75; 19.79; 19.9; 22.21 | 0.05 |
Summary
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.
Eligibility Criteria
Inclusion Criteria
- a) Premature infant born at gestational age less than 34 weeks
- b) Birth weight less than 1000 grams
- c) Legally authorized representative is able to provide written informed consent within the first 72 hours of life, prior to the performance of an protocol-specified evaluations or procedures
Exclusion Criteria
- a) infants with known metabolic disorder
- b) infants with known congenital gastrointestinal anomaly
- c) infants who are deemed to be inappropriate for enrollment per attending neonatologist
Data sourced from ClinicalTrials.gov (NCT01955044). 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.