Status:
COMPLETED
Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
24-96 years
Phase:
PHASE1
PHASE2
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 bronchopulmona...
Detailed Description
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-analys...
Eligibility Criteria
Inclusion
- Infants wtih birth weights from 401-1,000g
- Receiving mechanical ventilation or supplemental oxygen at 24-96 hours of age
Exclusion
- 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
Key Trial Info
Start Date :
January 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1999
Estimated Enrollment :
807 Patients enrolled
Trial Details
Trial ID
NCT01203488
Start Date
January 1 1996
End Date
July 1 1999
Last Update
September 26 2017
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Palo Alto, California, United States, 94304
2
Yale University
New Haven, Connecticut, United States, 06504
3
George Washington University
Washington D.C., District of Columbia, United States, 20052
4
University of Miami
Miami, Florida, United States, 33136