Vitamin E for Extremely Preterm Infants

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Center for Research Resources (NCRR)
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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