Darbepoetin for Preterm Infants
(Darbe Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What data supports the effectiveness of the drug Darbepoetin for preterm infants?
Is Darbepoetin safe for use in preterm infants?
Research shows that Darbepoetin has been studied for safety in preterm infants, with trials indicating it is generally safe when used for conditions like anemia and brain protection. It has been used to reduce the need for blood transfusions and may help protect the brain, with no major safety concerns reported in these studies.12346
How is the drug Darbepoetin unique for preterm infants?
Darbepoetin is unique for preterm infants because it is a long-acting erythropoiesis-stimulating agent (ESA) that not only helps reduce the need for blood transfusions by promoting red blood cell production but also shows promise in protecting the brain and improving neurodevelopmental outcomes.12347
What is the purpose of this trial?
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
Research Team
Robin Ohls, MD
Principal Investigator
University of Utah
Eligibility Criteria
This trial is for preterm infants born between 23 and nearly 29 weeks of gestation, who are less than one day old. It's not for babies with genetic or heart defects, brain anomalies, high blood count, seizures, clotting disorders, very high blood pressure without medication support, or if they're already getting similar treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Preterm infants receive weekly Darbepoetin or placebo during the neonatal period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended follow-up
Subjects will be seen for follow-up at 4-5 years and 6-7 years corrected age to assess long-term outcomes
Treatment Details
Interventions
- Darbepoetin
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
NICHD Neonatal Research Network
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator