Pediatric Trials

Vitamin E for Extremely Preterm Infants

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

NICHD Neonatal Research Network

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Stanford Investigator(s):

Intervention(s):

  • Drug: Vitamin E
  • Drug: Placebo

Phase:

Phase 1

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

Ages Eligible for Study

N/A - 4 Hours

Genders Eligible for Study

All

Now accepting new patients

Contact Information

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