PUFA Supplementation in Premature Infants

Not Applicable

Completed

• Conditions: Premature, Extremely Low Birth Weight Infants; Polyunsaturated Fatty Acid Levels
• Interventions: Dietary Supplement: LCPUFA supplement; Dietary Supplement: placebo

• Registration Number: NCT01955044
• Lead Sponsor: NorthShore University HealthSystem

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-27
• Study First Submitted QC: 2013-09-27
• Study First Posted: 2013-10-07
• Primary Completion: 2015-04
• Results First Submitted: 2016-02-26
• Results First Submitted QC: 2016-02-26
• Results First Posted: 2016-03-29
• Study Completion: 2016-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"low" dose LCPUFA	LCPUFA supplement	the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
"high" dose LCPUFA	LCPUFA supplement	the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
placebo	placebo	the "placebo" is a drop that will be administered to ELBW infants.

Primary Outcome Measures

Name	Time	Method
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels	2 weeks of life	LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants

Secondary Outcome Measures

Name	Time	Method
LCPUFA Levels	8 weeks of life	LCPUFA levels will be measured at 8 weeks of life.

Trial Locations

Locations (3)

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