NCT05537454

Maternal Stress, Milk Composition, and Preterm Neurodevelopment

Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 28 Weeks – 34 Weeks
• Healthy volunteers: Not accepted

Summary

This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.

Detailed description

The proposed study will address our novel hypothesis that maternal stress is associated with feeding outcomes and markers of impaired neurodevelopment for preterm infants and alters human milk and infant gut profiles in ways that affect preterm neurodevelopment. Mothers and their preterm infants (28-34 weeks gestation at birth) will be recruited to determine if: (1) variation in postnatal stress among mothers of very preterm infants relates to the total volume or proportion of maternal milk provided to her infant in the NICU and if (2) variation in maternal postnatal stress relates to her preterm infant's neurocognitive status at NICU discharge and 4 months corrected age. This project also involves collection/storage of maternal milk and infant fecal samples for multi-omics analyses. More specifically, the study will address: (3A) Is maternal postnatal stress associated with the metabolomic and microbiome characteristics of the infant's gut and/or the milk composition?, and (3B) Do milk composition differences relate to infant neurodevelopment? The aims of the proposed study contribute to our overarching research goal, which is to improve neurodevelopmental health for preterm infants by building the health and resilience of the mother-milk-infant triad.

Conditions

• Prematurity

Timeline

• Start date: 2022-12-09
• Primary completion: 2027-07-31
• Completion: 2030-07-31
• First posted: 2022-09-13
• Last updated: 2025-09-10

Locations

1 site across 1 country: United States