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Trial of Erythropoietin Neuroprotection in Extremely Preterm Infants (PENUT)



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The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies.  Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

The purpose of this trial is to determine if recombinant human erythropoietin (Epo) will improve developmental outcomes in extremely preterm infants.

Each year in the U.S., approximately 50,000 infants are born extremely prematurely—before 28 weeks of gestation.  Term gestation is 40 weeks.  Many of these infants are at a high risk for developing long-term developmental and neurological problems.  These problems may include cerebral palsy, deafness, blindness, and mental retardation.  Premature infants are most vulnerable in the first days after birth, but their brain remains at risk for injury until they are close to their due date.

Epo, a promising novel neuroprotective drug, may lessen the risk of long-term developmental and neurological problems if given when the infant’s brain is at risk.

In this trial, researchers want to determine if Epo can protect premature infants from having neurological problems.  They also will find out if a higher dose of Epo is safe for premature infants.  In PENUT, 940 premature infants will be randomized into one of two groups—Epo and non-Epo.  The Epo group will receive the study drug.  The non-Epo group will receive a placebo or an inactive substance.  Participants will undergo several procedures including an ultrasound of the head, blood draws, and urine collection.  Study researchers also may collect spinal fluid from participants if a spinal tap is performed for clinical reasons.  Follow-up will include four telephone interviews and one in-person clinic visit at two years of age.  Duration of the trial for participants is about two years.

Knowledge gained from this study may provide scientists with information on how to improve developmental and neurological outcomes in premature infants.

Eligibility Criteria:

INCLUSION:

  • Patients in the neonatal intensive care unit born between 24-27 weeks of gestation
  • Less than 24 hours of age
  • Parental informed consent

EXCLUSION:

  • Major life-threatening anomalies, such as brain, cardiac, or chromosomal anomalies
  • Hematologic crises such as disseminated intravascular coagulation (DIC), or hemolysis due to blood group incompatibilities [DIC is a disorder in which the proteins that control blood clotting become over active.]
  • Polycythemia (hematocrit >65%)
  • Congenital infection

Study Design: 

Interventional

Study Locations: 

Multiple U.S. locations

For more information:

Contact: Dr. Sandra Juul; Tel: 206-221-6814, email: sjuul.@uw.edu; or visit: http://clinicaltrials.gov/ct2/show/NCT01378273 or https://penut-trial.org/.

Last Reviewed February 10, 2014