Overview

This trial is active, not recruiting.

Conditions premature, extremely low birth weight infants, polyunsaturated fatty acid levels
Treatments lcpufa supplement, placebo
Sponsor NorthShore University HealthSystem Research Institute
Collaborator Ann & Robert H Lurie Children's Hospital of Chicago
Start date September 2013
End date April 2015
Trial size 30 participants
Trial identifier NCT01955044, MJN 8662

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
lcpufa supplement PUFA supplement
(Experimental)
the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
lcpufa supplement PUFA supplement
(Placebo Comparator)
the "placebo" is a drop that will be administered to ELBW infants.
placebo

Primary Outcomes

Measure
long-chain polyunsaturated fatty acid (LCPUFA) levels
time frame: 2 weeks of life

Secondary Outcomes

Measure
LCPUFA levels
time frame: 8 weeks of life
resolvin levels
time frame: 8 weeks of life
resolvin levels
time frame: 2 weeks of life

Eligibility Criteria

Male or female participants up to 72 hours old.

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

Additional Information

Official title Early DHA Supplementation in Extremely Low Birth Weight Infants
Principal investigator Michael S Caplan, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by NorthShore University HealthSystem Research Institute.