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Vitamin E for Extremely Preterm Infants
Recruiting
I'm InterestedTrial ID: NCT01193270
Purpose
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 less than 1000 grams birth weight). This pilot will examine whether a single
dose of vitamin E will be absorbed into the infants' bloodstreams with resulting serum
α-tocopherol level in the target range of 1-3 mg/dl.
Official Title
Single-Dose Vitamin E for Prevention of Mortality and Morbidity in Extremely Preterm Infants: Pilot Study
Eligibility
Inclusion Criteria:
- Less than 27 completed weeks gestational age
- Birth weight less than 1,000 grams
- Inborn infants
Exclusion Criteria:
- 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
Intervention(s):
drug: Vitamin E
drug: Placebo
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
M Bethany Ball
6507258342