PUFA Supplementation in Premature Infants

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.

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.

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