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



Status:Completed
Conditions:Bronchitis, Obesity Weight Loss, Hospital, Women's Studies, Pulmonary, Pulmonary
Therapuetic Areas:Endocrinology, Pulmonary / Respiratory Diseases, Other, Reproductive
Healthy:No
Age Range:Any
Updated:9/28/2017
Start Date:January 1996
End Date:July 1999

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

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.

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.

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
We found this trial at
11
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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920 Madison Ave
Memphis, Tennessee 38163
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Memphis, TN
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Providence, RI
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Cincinnati, Ohio 45267
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Cleveland, OH
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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Palo Alto, California 94304
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Washington, D.C., District of Columbia 20052
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Washington, D.C.,
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