Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants (Vitamin A)
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|ClinicalTrials.gov Identifier: NCT01203488|
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : September 26, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Bronchopulmonary Dysplasia Respiration, Artificial Respiratory Distress Syndrome, Newborn Sepsis||Drug: Vitamin A Other: Sham Procedure||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||807 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight|
|Study Start Date :||January 1996|
|Actual Primary Completion Date :||July 1997|
|Actual Study Completion Date :||July 1999|
Vitamin A group.
Drug: Vitamin A
5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.
Sham Comparator: Control
Sham procedure Control group.
Other: Sham Procedure
Control infants received a sham procedure rather than placebo injections.
- 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.
- 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).
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|Ages Eligible for Study:||24 Hours to 96 Hours (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Infants wtih birth weights from 401-1,000g
- Receiving mechanical ventilation or supplemental oxygen at 24-96 hours of age
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203488
|United States, California|
|Palo Alto, California, United States, 94304|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06504|
|United States, District of Columbia|
|George Washington University|
|Washington, D.C., District of Columbia, United States, 20052|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Georgia|
|Atlanta, Georgia, United States, 30303|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Ohio|
|Cincinnati Children's Medical Center|
|Cincinnati, Ohio, United States, 45267|
|Case Western Reserve University, Rainbow Babies and Children's Hospital|
|Cleveland, Ohio, United States, 44106|
|United States, Rhode Island|
|Brown University, Women & Infants Hospital of Rhode Island|
|Providence, Rhode Island, United States, 02905|
|United States, Tennessee|
|University of Tennessee|
|Memphis, Tennessee, United States, 38163|
|United States, Texas|
|University of Texas Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75235|
|Study Director:||Jon E. Tyson, MD MPH||University of Texas Southwestern Medical Center|
|Principal Investigator:||William Oh, MD||Brown University, Women and Infants Hospital|
|Principal Investigator:||Joel Verter, PhD||George Washington University Biostatistics Center|
|Principal Investigator:||Richard A. Ehrenkranz, MD||Yale University|
|Principal Investigator:||Barbara J. Stoll, MD||Emory University|
|Principal Investigator:||James A. Lemons, MD||Indiana University|
|Principal Investigator:||David K. Stevenson, MD||Stanford University|
|Study Director:||Charles R. Bauer, MD||University of Miami|
|Principal Investigator:||Sheldon B. Korones, MD||University of Tennessee|
|Principal Investigator:||Edward F. Donovan, MD||Case Western Reserve University|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Chronic Lung Disease
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ventilator-Induced Lung Injury
Physiological Effects of Drugs