NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

PUFA Supplementation in Premature Infants

NCT01955044

CompletedNA

Sponsor: Endeavor Health

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

Interventions: LCPUFA supplement, placebo

Countries: United States

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 overview

Sex: ALL

Age: — to 72 Hours

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (3)

Chicago, Illinois, United States
Chicago, Illinois, United States
Evanston, Illinois, United States