Vitamin E for Extremely Preterm Infants

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Trial ID: NCT01193270

Age - N/A-4 Hours Condition - Neonatal and Developmental Medicine Gender - All Accepting Healthy Volunteers - yes

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

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Intervention(s):

drug: Vitamin E

drug: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
M Bethany Ball
6507258342

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