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Darbepoetin Exposure and Preterm Respiratory Outcomes, Oscillometry, and Function Study (DarbE-PROOF Study)

Award Number: R01HL182817
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 05/31/2031

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Darbepoetin Exposure and Preterm Respiratory Outcomes, Oscillometry, and Function Study (DarbE-PROOF Study) - PROJECT SUMMARY/ABSTRACT Improved survival of extremely preterm infants has not translated into improved respiratory outcomes. The NHLBI-funded “Darbepoetin Trial to Improve Red Cell Mass and Neurodevelopment in Preterms” (Darbe Trial) was a multicenter masked, randomized trial of extremely preterm infants to test the hypothesis that darbepoetin leads to improved neurodevelopment at 2 years old. While there was no difference in neurodevelopmental outcomes, there was a significant reduction in grade 2-3 bronchopulmonary dysplasia (BPD), consistent with preclinical data suggesting that erythropoiesis stimulating agents such as darbepoetin are lung-protective. The Darbepoetin Kindergarten Development Study (Darbe-KIDS) is following-up these infants at early school age to evaluate neurodevelopmental outcomes. However, no respiratory outcomes are included. In the current application we propose the Darbepoetin Exposure and Preterm Respiratory Outcomes, Oscillometry, and Function (DarbE-PROOF) Study in which we will evaluate lung mechanics using oscillometry and functional respiratory outcomes at early school age. The specific aims of DarbE-PROOF are to (1) test the impact of neonatal exposure to darbepoetin versus placebo on lung mechanics and functional respiratory outcomes at 6.0- 8.0 years corrected age; (2) validate current definitions of neonatal lung disease, BPD diagnosed at 36 weeks’ postmenstrual age and post-prematurity respiratory disease (PPRD) diagnosed at 2 years corrected age, using functional respiratory outcomes and lung mechanics at school age in a high-risk population of former extremely preterm infants with detailed longitudinal respiratory data available. We hypothesize that children treated with darbepoetin will have improved lung mechanics on oscillometry testing and functional respiratory outcomes, assessed using the 6 minute walk test, VO2 max 3 minute-step test, and the International Study of Asthma and Allergies in Childhood questionnaire, as compared to those treated with placebo. Further, we hypothesize that PPRD will be a better predictor of functional respiratory outcomes than BPD among children born extremely preterm. DarbE-PROOF builds on the collective expertise in respiratory assessment and follow-up of preterm infants among our core group of highly collaborative, interdisciplinary investigators at 6 clinical sites that enrolled children in the Darbe Trial. In addition, DarbE-PROOF capitalizes on the existing infrastructure that supports DARBE-KIDS school age study funded by NHLBI. DarbE-PROOF will provide a comprehensive evaluation of respiratory health over time among children at highest risk of chronic lung disease. In addition to providing critical data about the effects of darbepoetin on respiratory outcomes through school age, DarbE-PROOF will yield novel and important data on respiratory outcomes in a large contemporary cohort of extremely preterm infants treated in U.S. neonatal intensive care units. Results of this study will directly impact interpretation of the Darbe Trial and influence whether darbepoetin should be adopted to improve outcomes for preterm infants.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $754,328 )
2026	2026	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Lung Diseases Research	000	1	8/28/2026	NEW	$754,328
														Subtotal = $754,328

Grand Total All Awards = $754,328

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Darbepoetin Exposure and Preterm Respiratory Outcomes, Oscillometry, and Function Study (DarbE-PROOF Study)

Award Number: R01HL182817

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 05/31/2031

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