PUFA Supplementation in Premature Infants

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

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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