Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin (BRITE)

NCT01207778 COMPLETED Results posted

Approximately 60,000 premature infants are born each year who weigh less than 1,500 grams,many of whom sustain brain damage because of their prematurity. This study is designed to evaluate the long-term developmental effects of one promising neuroprotective treatment,erythropoietin (Epo), when given in the neonatal period. Using detailed neurodevelopmental testing and state-of-the-art brain imaging, we hope to determine whether this is an effective treatment to prevent brain injury associated with prematurity, and to lay the groundwork for further studies to improve the developmental outcome of infants delivered prematurely.

Details

Lead sponsor	University of New Mexico
Status	COMPLETED
Enrolment	77
Start date	2010-03
Completion	2020-12-31

Conditions

• Prematurity

Primary outcomes

• Full Scale IQ, Performance IQ, Verbal IQ, Executive Function — 42-48 months and 66-72 months
  Infants who received ESAs during their initial hospitalization will perform significantly better on measures of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI) full scale IQ, performance IQ, verbal IQ, and executive function. Scores are standardized, 100 is an average score with a standard deviation of 15. Higher scores are better. Test scores range from 41 to 160.

Countries

United States