Vitamin E for Extremely Preterm Infants

Completed · Phase 1 · Has a placebo group

Conditions studied: Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature, Intracranial Hemorrhages

In brief

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.

Key facts

Study ID

NCT01193270

Run by

NICHD Neonatal Research Network

People needed

93

Starts

2010-10-01

Expected to finish

2011-08-01

Last updated by the study team

2015-11-11

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Less than 27 completed weeks gestational age
• Birth weight less than 1,000 grams
• Inborn infants

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• RTI International — Durham, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.