PUFA Supplementation in Premature Infants
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
Early DHA Supplementation in Extremely Low Birth Weight Infants
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.
formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain
docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.
This will be a multi-center, randomized, placebo controlled, double blind trial.
Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.
ELBW infants will be enrolled into this study.
Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.
ELBW infants will be enrolled into this study.
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
We found this trial at
3
sites
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