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Limited versus Extended Trophic Feeding among Very Preterm Newborns: Neurodevelopment and the Gut-Brain Axis (LET-FEED: Gut-Brain Axis)

Award Number: R01HD122688
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2031

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Limited versus Extended Trophic Feeding among Very Preterm Newborns: Neurodevelopment and the Gut-Brain Axis (LET-FEED: Gut-Brain Axis) - Project Abstract Very preterm (VP; <32 weeks’ gestation) newborns are at high risk for sepsis, mortality, and long-term neurodevelopmental impairment. Early feeding practices influence the risk of sepsis and neurodevelopment attainment through effects on the developing gut-brain axis. Current standard practice involves initiating trophic human milk feeds (~20 mL/kg/day, called “trophic feeds”) with concurrent IV fluids and subsequent gradual advancement to full enteral feeds. Yet, because no clinical trials have directly compared early feeding strategies, meta-analyses suggest advancing feeds “within 4 days”, leaving uncertainty over whether 1 or 3 days of trophics is optimal. Consequently, feeding practices, and the care of VP newborns, vary widely across NICUs worldwide. To address this gap, we are conducting a multi-site (across 5 US states), individually randomized clinical trial (LET-FEED; NCT06893939; Funder: Gerber Foundation) comparing limited (1 day) versus extended (3 days) of trophic feeds in 350 VP newborns with the primary outcome of late-onset sepsis. However, current funding does not extend beyond NICU discharge. As both the neonatal brain and gut microbiome undergo rapid concurrent development, and emerging evidence links early feeding practices to gut microbial succession, synaptogenesis, and neurogenesis, with downstream implications on long-term neurodevelopmental attainment. Our pilot work suggests limited trophic feeding shapes distinct microbial signatures within the gut microbiome, but whether such differences translate to long-term neurodevelopment remains unknown. We aim to determine whether early feeding practices alter the developing gut-brain axis, specifically microbial succession and neurodevelopmental attainment, through 2 years corrected age (CA). We hypothesize that limited trophic feeds, by reducing IV exposure and increasing early enteral intake, will promote beneficial colonization, reduce pathobionts (e.g. Klebsiella and E. coli) and improve neurodevelopmental outcomes. We seek to test this hypothesis through the following complementary but independent specific aims: (1) Compare 2-year neurodevelopmental outcomes based on exposure to limited versus extended trophic feeds; (2) Characterize gut microbial succession through 2 years CA based on feeding group exposure; and, (3) Evaluate the relationship between stool metagenomic profiling (including bacterial, viral, and fungal profiles) and neurodevelopmental outcomes at 2 years CA, including mediation of feeding effects. This trial will fill a critical evidence gap in neonatal nutrition with direct translational impact on VP newborn care worldwide while concurrently advancing mechanistic understanding of the developing gut-brain axis that has the potential to lead to cutting-edge scientific breakthroughs in reducing risk of long-term disability for this vulnerable population.


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 = $718,447 )
2026	2026	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	000	1	9/17/2026	NEW	$718,447
														Subtotal = $718,447

Grand Total All Awards = $718,447

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Limited versus Extended Trophic Feeding among Very Preterm Newborns: Neurodevelopment and the Gut-Brain Axis (LET-FEED: Gut-Brain Axis)

Award Number: R01HD122688

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/10/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2031

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