CompletedPhase 1

Vitamin E for Extremely Preterm Infants

United States93 participantsStarted 2010-10

Plain-language 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.

Who can participate

Age range4 Hours

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Serum tocopherol levels

Timeframe: Birth to 7 days

Trial details

NCT IDNCT01193270

SponsorNICHD Neonatal Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2011-08

View on ClinicalTrials.gov More Infant, Newborn trials