Maternal Stress, Milk Composition, and Preterm Neurodevelopment

University of Minnesota (UMN)

Status: Enrolling

Conditions: Prematurity

Study type: Observational

Funder types: Other

Identifiers

NCT05537454

SPH-2022-31233

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 28 to 34 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• preterm infant born between 28 0/7 and 34 6/7 weeks' gestation that are medically stable for study procedures
• mother of preterm infant meeting criteria and a) 18 to 45 years of age at the time of delivery

Exclusion criteria

• infants: major congenital anomalies, anticipated death, positive blood culture at birth, hypoxic ischemic encephalopathy, grade IV intraventricular hemorrhage, or plan to transfer care before discharge (35-37 weeks postmenstrual age).
• mothers: a) alcohol consumption >1 drink per week or any tobacco consumption during pregnancy, b) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth