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

This study has been completed.
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01203488
First received: September 15, 2010
Last updated: January 9, 2011
Last verified: September 2010
History of Changes

September 15, 2010
January 9, 2011
January 1996
July 1997   (final data collection date for primary outcome measure)
Chronic lung disease or death [ Time Frame: 36 weeks' postmenstrual age ] [ Designated as safety issue: Yes ]
Chronic lung disease was defined as the need for oxygen at 36 weeks' postmenstrual age.
Same as current
Complete list of historical versions of study NCT01203488 on ClinicalTrials.gov Archive Site
Sepsis [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
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).
Same as current
Not Provided
Not Provided
 
Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • 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
    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.
  • Experimental: Experimental
    Vitamin A group.
    Intervention: Drug: Vitamin A
  • Sham Comparator: Control
    Sham procedure Control group.
    Intervention: Other: Sham Procedure

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
807
July 1999
July 1997   (final data collection date for primary outcome measure)

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
Both
up to 96 Hours
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01203488
NICHD-NRN-0015, U10HD021373, U10HD027904, U01HD019897, U10HD027871, M01RR006022, U10HD027851, U10HD027856, M01RR000750, U10HD027880, M01RR000070, U10HD021397, U10HD021415, U10HD021364, U10HD027853, M01RR008084, U10HD034216, U10HD021385, U10HD034167, U10HD027881, M01RR000997
Yes
Jon E. Tyson, Lead Principal Investigator, University of Texas Southwestern Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP