Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants

Summary

This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours of age were enrolled. Subjects were randomized to either the Vitamin A or a control group. Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure rather than placebo injections.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Bronchopulmonary Dysplasia
• Respiration, Artificial
• Respiratory Distress Syndrome, Newborn
• Sepsis

Interventions

DRUG

Vitamin A

5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.

OTHER

Sham Procedure

Control infants received a sham procedure rather than placebo injections.

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Jon E. Tyson, MD MPH · University of Texas Southwestern Medical Center

• William Oh, MD · Brown University, Women and Infants Hospital

• Joel Verter, PhD · George Washington University Biostatistics Center

• Richard A. Ehrenkranz, MD · Yale University

• Barbara J. Stoll, MD · Emory University

• James A. Lemons, MD · Indiana University

• David K. Stevenson, MD · Stanford University

• Charles R. Bauer, MD · University of Miami

• Sheldon B. Korones, MD · University of Tennessee

• Edward F. Donovan, MD · Case Western Reserve University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

24 Hours

Max Age

96 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1996-01-31

Primary Completion

1997-07-31

Completion

1999-07-31

Countries

• United States

Study Locations