Early DHA Supplementation in Very Low Birth Weight Infants

N/ACompletedNCT03192839

Mead Johnson Nutrition30 enrolled

Overview

This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Prematurity

Interventions

Low dose PUFAOTHER

Low dose PUFA

High dose PUFAOTHER

High dose PUFA

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMax age: 3 Days

Medical Language ↔ Plain English

Inclusion Criteria: * Very low birth weight infants weighing less than 1500 grams * Consent signed within 72 hours of life Exclusion Criteria: * Infants with know metabolic disorder * Infants with known congenital GI anomaly * Infants who are deemed to be inappropriate for enrollment per attending neonatologist

Locations (2)

Rush University Medical Center

Chicago, Illinois, United States

North Shore University Health System

Evanston, Illinois, United States

Outcomes

Primary Outcomes

Red Blood Cell polyunsaturated fatty acids (PUFA) levels

Time frame: 2 weeks of age

Secondary Outcomes

Red Blood Cell PUFA levels

Time frame: 8 weeks of age

Feeding tolerance

Full enteral feed of 120 kcal/kg/day

Time frame: 8 weeks

Incidence of necrotizing enterocolitis

Time frame: 8 weeks

Incidence of bronchopulmonary dysplasia

Time frame: 8 weeks

Data from ClinicalTrials.gov

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