650 Participants Needed

Darbepoetin for Preterm Infants

(Darbe Trial)

Recruiting at 15 trial locations
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: NICHD Neonatal Research Network
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

Research shows that Darbepoetin, a drug similar to erythropoietin, has been effective in reducing the need for blood transfusions and may help protect the brain in preterm infants, potentially improving their development.12345

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

RO

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

23 0/7-28 6/7 weeks gestation
My baby is less than 24 hours old.
My baby was born prematurely.

Exclusion Criteria

I have a bleeding or blood disorder.
Hematocrit > 60%
Congenital thrombotic disease
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Preterm infants receive weekly Darbepoetin or placebo during the neonatal period

9 weeks
Weekly visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

22-26 months
Visits at 22-26 months corrected age

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

Long-term

Treatment Details

Interventions

  • Darbepoetin
  • Placebo
Trial Overview The study tests whether giving Darbepoetin (Darbe) to premature babies weekly can improve their brain development and cognitive skills by the time they're about two years old. They'll compare results from babies given Darbe against those given a placebo.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DarbepoetinExperimental Treatment1 Intervention
Darbepoetin 10 micrograms/kg/once every week (IV or SC)
Group II: PlaceboPlacebo Group1 Intervention
Equal volume normal saline for IV administration, or sham dosing

Find a Clinic Near You

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials
62
Recruited
209,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Findings from Research

The study assessed the safety and feasibility of administering a single dose of Darbepoetin alpha (Darbe) to 21 neonates with mild neonatal encephalopathy, and found no adverse events reported in either the Darbe or placebo groups.
Both groups showed average developmental scores on the Bayley Scales of Infant and Toddler Development, indicating that while the treatment was safe, further large-scale trials are needed to evaluate the efficacy of Darbe in improving outcomes for these infants.
Darbepoetin as a neuroprotective agent in mild neonatal encephalopathy: a randomized, placebo-controlled, feasibility trial.DuPont, TL., Baserga, M., Lowe, J., et al.[2023]
In a study involving 90 preterm neonates (45 treated with darbepoetin alfa and 45 controls), the administration of darbepoetin alfa did not significantly affect neutrophil counts or the rates of neutropenia compared to the control group.
There were no differences in the occurrence of neutropenia (ANC ≤1000/μL) or severe neutropenia (ANC ≤500/μL) between the darbe-treated and control neonates, indicating that darbepoetin alfa does not impact neutrophil levels in this population.
Characterization of Neutropenia in Preterm Neonates Following Administration of Darbepoetin Alfa.Andrews, N., Friedman, S., Dunham, M., et al.[2023]
Darbepoetin, a long-acting erythropoiesis-stimulating agent (ESA), has shown significant effectiveness in promoting red blood cell production in both term and preterm infants, potentially reducing the need for blood transfusions.
In addition to its erythropoietic effects, darbepoetin may also offer neuroprotective benefits, helping to prevent and treat brain injuries in infants, which highlights its dual role in neonatal care.
Darbepoetin Administration in Term and Preterm Neonates.Patel, S., Ohls, RK.[2018]

References

Darbepoetin as a neuroprotective agent in mild neonatal encephalopathy: a randomized, placebo-controlled, feasibility trial. [2023]
Cognitive outcomes of preterm infants randomized to darbepoetin, erythropoietin, or placebo. [2021]
Characterization of Neutropenia in Preterm Neonates Following Administration of Darbepoetin Alfa. [2023]
Darbepoetin Administration in Term and Preterm Neonates. [2018]
Recombinant human erythropoietin improves neurological outcomes in very preterm infants. [2018]
Darbepoetin administration to neonates undergoing cooling for encephalopathy: a safety and pharmacokinetic trial. [2018]
Darbepoetin Alfa for Late-onset Anemia in Neonates with Rhesus Hemolytic Disease. [2023]
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