ClinicalTrials.Veeva

Menu

PUFA Supplementation in Premature Infants

N

NorthShore University HealthSystem

Status

Completed

Conditions

Polyunsaturated Fatty Acid Levels
Premature, Extremely Low Birth Weight Infants

Treatments

Dietary Supplement: LCPUFA supplement
Dietary Supplement: placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01955044
EH13-334

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

Under 72 hours old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 3 patient groups, including a placebo group

"high" dose LCPUFA
Experimental group
Description:
the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
Treatment:
Dietary Supplement: LCPUFA supplement
"low" dose LCPUFA
Experimental group
Description:
the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
Treatment:
Dietary Supplement: LCPUFA supplement
placebo
Placebo Comparator group
Description:
the "placebo" is a drop that will be administered to ELBW infants.
Treatment:
Dietary Supplement: placebo

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems