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High-energy human milk diets in the first two weeks after birth to reduce the severity of respiratory morbidity in extremely preterm infants

Award Number: R34HL183268
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2026
PERIOD OF PERFORMANCE END DATE: 03/31/2029

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High-energy human milk diets in the first two weeks after birth to reduce the severity of respiratory morbidity in extremely preterm infants - PROJECT SUMMARY This hypothesis-driven, patient-oriented pilot randomized clinical trial will evaluate whether providing a high- energy human milk diet during the first two weeks after birth reduces respiratory morbidity in extremely preterm (EPT) infants. EPT infants, born at 28 weeks of gestation or earlier, have immature lungs and a high risk of developing bronchopulmonary dysplasia (BPD)—a chronic lung disease that increases mortality and long-term developmental complications. Early enteral nutrition is critical for lung development, yet most EPT infants receive insufficient energy during the first 14 days after birth. Docosahexaenoic acid (DHA) and arachidonic acid (ARA) supplementation is a promising strategy to increase energy intake through human milk, but there is no consensus on whether fat- enriched or protein-enriched diets are more beneficial for improving lung function. Building on findings from our recent NIH-funded trial, which demonstrated that protein-enriched diets improved growth and potentially reduced BPD severity, we will now assess whether a DHA/ARA-enriched exclusive human milk diet can achieve superior benefits. In this trial, we will randomize 150 EPT infants to receive either an exclusive human milk diet enriched with a commercially available DHA/ARA supplement or a standard, exclusive human milk diet during the first 14 days after birth. The primary outcome is the severity of respiratory morbidity at term equivalent age. We will also evaluate the feasibility of using non-invasive oscillometry to measure lung function in this population. This study will inform the design of a larger clinical trial and may establish that early enteral energy provision— unlike parenteral nutrition—provides measurable respiratory benefits. The findings could reshape neonatal nutrition strategies and optimize care for preterm infants at risk of BPD.


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 = $180,860 )
2026	2026	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Lung Diseases Research	000	1	3/30/2026	NEW	$180,860
														Subtotal = $180,860

Grand Total All Awards = $180,860

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High-energy human milk diets in the first two weeks after birth to reduce the severity of respiratory morbidity in extremely preterm infants

Award Number: R34HL183268

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2026

PERIOD OF PERFORMANCE END DATE: 03/31/2029

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