Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Vitamin A
Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight
21 other identifiers
interventional
807
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 1996
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 1999
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
September 16, 2010
CompletedSeptember 26, 2017
September 1, 2017
1.5 years
September 15, 2010
September 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chronic lung disease or death
Chronic lung disease was defined as the need for oxygen at 36 weeks' postmenstrual age.
36 weeks' postmenstrual age
Secondary Outcomes (1)
Sepsis
5 days
Study Arms (2)
Experimental
EXPERIMENTALVitamin A group.
Control
SHAM COMPARATORSham procedure Control group.
Interventions
5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Stanford University
Palo Alto, California, 94304, United States
Yale University
New Haven, Connecticut, 06504, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
University of Miami
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30303, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
Related Publications (5)
Stark AR, Tyson JE, Hibberd PL. Variation among institutional review boards in evaluating the design of a multicenter randomized trial. J Perinatol. 2010 Mar;30(3):163-9. doi: 10.1038/jp.2009.157. Epub 2009 Oct 1.
PMID: 19798046BACKGROUNDKennedy KA, Stoll BJ, Ehrenkranz RA, Oh W, Wright LL, Stevenson DK, Lemons JA, Sowell A, Mele L, Tyson JE, Verter J. Vitamin A to prevent bronchopulmonary dysplasia in very-low-birth-weight infants: has the dose been too low? The NICHD Neonatal Research Network. Early Hum Dev. 1997 Jul 24;49(1):19-31. doi: 10.1016/s0378-3782(97)01869-0.
PMID: 9179535RESULTTyson JE, Wright LL, Oh W, Kennedy KA, Mele L, Ehrenkranz RA, Stoll BJ, Lemons JA, Stevenson DK, Bauer CR, Korones SB, Fanaroff AA. Vitamin A supplementation for extremely-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 1999 Jun 24;340(25):1962-8. doi: 10.1056/NEJM199906243402505.
PMID: 10379020RESULTAmbalavanan N, Tyson JE, Kennedy KA, Hansen NI, Vohr BR, Wright LL, Carlo WA; National Institute of Child Health and Human Development Neonatal Research Network. Vitamin A supplementation for extremely low birth weight infants: outcome at 18 to 22 months. Pediatrics. 2005 Mar;115(3):e249-54. doi: 10.1542/peds.2004-1812. Epub 2005 Feb 15.
PMID: 15713907RESULTRysavy MA, Li L, Tyson JE, Jensen EA, Das A, Ambalavanan N, Laughon MM, Greenberg RG, Patel RM, Pedroza C, Bell EF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Should Vitamin A Injections to Prevent Bronchopulmonary Dysplasia or Death Be Reserved for High-Risk Infants? Reanalysis of the National Institute of Child Health and Human Development Neonatal Research Network Randomized Trial. J Pediatr. 2021 Sep;236:78-85.e5. doi: 10.1016/j.jpeds.2021.05.022. Epub 2021 May 15.
PMID: 34004189DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
September 15, 2010
First Posted
September 16, 2010
Study Start
January 1, 1996
Primary Completion
July 1, 1997
Study Completion
July 1, 1999
Last Updated
September 26, 2017
Record last verified: 2017-09