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NCT Number: NCT01203488

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

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.

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Key information

Conditions

Infant, Newborn Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Low Birth Weight Infant, Newborn, Diseases Infant, Premature Infant, Premature, Diseases Infant, Small for Gestational Age Infections Inflammation Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases Ventilator-Induced Lung Injury

Age range

24 hour–96 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford University, Palo Alto, California, United States

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About this study

Infants with extremely low birth weights (≤1,000 g) have low plasma and tissue concentrations of vitamin A, and vitamin A deficiency may predispose these infants to chronic lung disease. A meta-analysis of clinical trials of vitamin A supplementation for preterm infants revealed a 17% increase in the rate of survival without chronic lung disease, which approached statistical significance.

This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A than that used in previous trials in extremely-low-birth-weight (ELBW) infants. We hypothesized that vitamin A supplementation would increase the rate of survival without bronchopulmonary dysplasia and reduce the risk of sepsis.

Infants with birth weights from 401-1000g and who received 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.

Serum vitamin A was measured in a central laboratory at base line and at 28 days in the first 300 infants. On study day 28 (two to three days after the last treatment and immediately after a blood sample was collected), the relative dose-response was evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Vitamin A

Drug

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

Sham Procedure

Other

Control infants received a sham procedure rather than placebo injections.

Primary outcomes

  1. Chronic lung disease or death

    Time frame: 36 weeks' postmenstrual age

    Chronic lung disease was defined as the need for oxygen at 36 weeks' postmenstrual age.

Secondary outcomes

  1. Sepsis

    Time frame: 5 days

    Sepsis was defined on the basis of a positive blood culture and treatment with antibiotics for at least five days (unless the infant died within five days).

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight

Acronym: Vitamin A

Important dates

Study start
1996
Primary completion
1997
Study completion
1999
First posted
Sep 16, 2010
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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