Vitamin E for Extremely Preterm Infants
Trial ID or NCT#
NCT01193270
Status
RECRUITING
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 Criteria
Ages Eligible for Study: Younger than 4 Hours
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
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
Contact us to find out if this trial is right for you.
Contact
M Bethany Ball
6507258342
View on ClinicalTrials.gov
