PUFA Supplementation in Premature Infants

Completed · Not applicable · Has a placebo group

Conditions studied: Premature, Extremely Low Birth Weight Infants, Polyunsaturated Fatty Acid Levels

In brief

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.

Key facts

Study ID

NCT01955044

Run by

Endeavor Health

People needed

30

Starts

2013-09-01

Expected to finish

2016-04-01

Last updated by the study team

2021-09-05

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Prentice Women's Hospital — Chicago, Illinois, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States

Full record on ClinicalTrials.gov

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