# Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterms - DCC

> **NIH NIH U01** · RESEARCH TRIANGLE INSTITUTE · 2021 · $777,666

## Abstract

PROJECT SUMMARY/ABSTRACT
Improving neurodevelopmental outcomes for the nearly 60,000 preterm infants born each year is a major
goal for neonatal care providers. A subset of these infants sustain a major intraventricular hemorrhage (IVH)
resulting in an increased incidence of developmental delay. Moreover, almost one-third of preterm infants
with normal head ultrasounds also develop cognitive delay. Although a variety of treatment strategies have
been evaluated, no specific treatment has been identified to improve neurodevelopmental outcomes in
preterm infants. One potential therapy involves administering erythropoiesis stimulating agents (ESAs) such
as erythropoietin (Epo) and Darbepoetin (Darbe, a longer acting ESA). Initially investigated for their effects
on decreasing transfusions in preterm infants, ESAs have been shown to be protective in the developing
brain, and thus possibly beneficial for very premature infants who are at risk for IVH, hypoxic-ischemic injury,
and developmental delay. We previously evaluated both hematologic and neurodevelopmental outcomes at
18-22 months corrected age in a multicenter trial of 99 preterm infants randomized to receive Epo, Darbe, or
placebo through 35 weeks postmenstrual age. ESA-treated infants received fewer transfusions and were
exposed to fewer donors. At 18-22 months ESA-treated infants had significantly higher cognitive scores and
lower rates of neurodevelopmental impairment, including no cerebral palsy. At 4 and 6 years of age, higher
cognitive and executive function scores were measured in ESA compared to placebo recipients. Darbe
recipients had improved executive function compared to Epo recipients while receiving one-third the doses,
thus providing evidence that Darbe might provide even greater benefit than Epo for preterm infants.
This proposal addresses our long-term goal of developing effective treatment strategies to improve
outcomes in preterm infants. Understanding the impact of increased hematocrit and decreased transfusions
in addition to the non-hematopoietic mechanisms of ESAs is necessary to achieve optimal developmental
outcomes. Applying the experience and rigor of the Neonatal Research Network infrastructure in performing
randomized placebo controlled trials, our specific aims are to evaluate the effect of Darbe administered in the
first 10 weeks of life to preterm infants born at 23 to 28 completed weeks gestational age on (1) donor and
transfusion requirements and measures of red cell mass, and (2) neurocognitive outcomes at 22-26 months
adjusted age. Hematocrit, transfusions, and donor exposures will be collected during hospitalization, and
neurodevelopmental outcome will be assessed through comprehensive testing at 22-26 months (Bayley
Scales of Infant Development III, executive function, and neurologic exam). If outcomes of the previous study
are confirmed, the use of Darbe could become standard of care and significantly improve the lives of
thousands of preterm infants.

## Key facts

- **NIH application ID:** 10152665
- **Project number:** 5U01HL136306-05
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** Abhik Das
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $777,666
- **Award type:** 5
- **Project period:** 2017-06-01 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10152665

## Citation

> US National Institutes of Health, RePORTER application 10152665, Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterms - DCC (5U01HL136306-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10152665. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*