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

Completed · Phase 1/Phase 2 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT01203488

Run by

NICHD Neonatal Research Network

People needed

807

Starts

1996-01-01

Expected to finish

1999-07-01

Last updated by the study team

2017-09-26

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants wtih birth weights from 401-1,000g
• Receiving mechanical ventilation or supplemental oxygen at 24-96 hours of age

You may not qualify if…

• Major congenital anomalies
• Congenital nonbacterial infection
• Infants diagnosed with a terminal illness (as indicated by a pH below 6.80 or by the presence of hypoxia with bradycardia for more than two hours)
• Infants who were to receive vitamin A in a parenteral fat emulsion or in doses exceeding recommendations for multivitamin preparations

Where it is running

• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• George Washington University — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Tennessee — Memphis, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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