# Targeting human milk fortification to improve preterm infant growth and brain development

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2021 · $745,364

## Abstract

Project Summary / Abstract
Despite marked improvement in survival in the past 3 decades, very preterm infants continue to experience
high rates (50-60%) of neurodevelopmental impairment after discharge from the neonatal intensive care unit
(NICU). These impairments burden children and families and incur large societal costs for early intervention
and special educational services. An important contributing factor to neurodevelopmental impairment is
extrauterine growth restriction, which is common (50%) and reflects undernutrition during the NICU
hospitalization. Normal brain development depends on the availability of key nutrients during specific sensitive
or critical periods, and preterm infants are entirely dependent on the nutrition they receive in the NICU during
the “brain growth spurt” of the third trimester. Nutritional strategies in the NICU that reduce undernutrition
during this critical period for brain development are likely to result in better long-term neurodevelopmental
outcomes. The American Academy of Pediatrics recommends a fortified human milk diet for all preterm infants,
and human milk use is rising in NICUs across the U.S. However, because human milk is highly variable in its
macronutrient content, consistently meeting nutrient requirements for human milk-fed infants is a challenge.
Evidence of slower weight gain and head growth in fortified human milk- vs. formula-fed very preterm infants
suggests that current human milk fortification strategies are inadequate to fully support their growth. The aim of
this study is to investigate a new, individualized approach to human milk fortification, leveraging technology
from the dairy industry to analyze human milk composition at the point of care and target fortification to ensure
that protein and energy intakes consistently meet recommendations. We are proposing to study this new
approach by conducting a randomized, controlled trial of individually targeted vs. standard fortification among
preterm infants receiving human milk (maternal milk plus donor milk if needed, no formula). Outcomes will
include physical growth and body composition (fat and fat-free mass), quantitative MRI to assess brain size
and microstructure, and neurodevelopment assessed across a range of domains (cognition, executive function,
attention, behavior) at 2 years’ corrected age. Our overarching goal is to improve long-term health and
developmental outcomes of very preterm infants through pragmatic, evidence-based innovations in nutritional
care during the NICU hospitalization. The impact of the current study will be to determine the benefits of
individually targeted human milk fortification not just to physical growth, but also to the structure and function of
the developing brain. These answers are needed to inform larger-scale clinical trials and for the translation of
this and other promising nutritional strategies into clinical practice. This work has the potential to benefit over
63,000 very preterm infan...

## Key facts

- **NIH application ID:** 10247537
- **Project number:** 5R01HD097327-03
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Mandy Brown Belfort
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $745,364
- **Award type:** 5
- **Project period:** 2019-09-01 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247537

## Citation

> US National Institutes of Health, RePORTER application 10247537, Targeting human milk fortification to improve preterm infant growth and brain development (5R01HD097327-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10247537. Licensed CC0.

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