Status:
COMPLETED
Vitamin E for Extremely Preterm Infants
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infant, Newborn
Infant, Small for Gestational Age
Eligibility:
All Genders
Up to 4 years
Phase:
PHASE1
Brief Summary
The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and l...
Detailed Description
Intraventricular hemorrhage (IVH) -- bleeding into the brain's ventricular system -- is one of the most common complications of prematurity, affecting an estimated 10-40% of very low birth weight (\<1...
Eligibility Criteria
Inclusion
- Less than 27 completed weeks gestational age
- Birth weight less than 1,000 grams
- Inborn infants
Exclusion
- Infant's treatment will be limited based on poor prognosis
- Umbilical cord or blood pH below 7.0
- Antenatally diagnosed brain abnormality, including hemorrhage
- Major congenital malformations, including those for which feeding is contraindicated
- Mother of infant enrolled in a clinical trial of vitamin E supplementation
- Mother of infant reports self administration of monovitamin supplements of vitamin E during pregnancy or labor
- Infant has received supplemental vitamin E (except multivitamin additive in parenteral nutrition or through enteral milk or formula feeds)
- Greater than four hours of age
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01193270
Start Date
October 1 2010
End Date
August 1 2011
Last Update
November 11 2015
Active Locations (16)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Stanford University
Palo Alto, California, United States, 94304
3
Yale University
New Haven, Connecticut, United States, 06504
4
Emory University
Atlanta, Georgia, United States, 30303