Maternal Stress, Milk Composition, and Preterm Neurodevelopment
- Conditions
- Prematurity
- Registration Number
- NCT05537454
- Lead Sponsor
- University of Minnesota
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maternal milk production inpatient 28-35 weeks postmenstrual age total volume (mL)
Maternal milk proportion inpatient 28-35 weeks postmenstrual age Proportion of maternal milk vs donor milk/formula (%)
Milk microbiome inpatient 28-35 weeks postmenstrual age Microbial diversity of milk samples
Maternal milk production 4 months corrected age 4 months corrected age total volume (mL)
Maternal milk proportion 4 months corrected age 4 months corrected age Proportion of maternal milk vs donor milk/formula (%)
Infant gut microbiome inpatient 28-35 weeks postmenstrual age Microbial diversity of fecal samples
Milk microbiome 4 months corrected age 4 months corrected age Microbial diversity of milk samples
Milk metabolome inpatient 28-35 weeks postmenstrual age Concentration of untargeted and targeted metabolites
Infant Neurodevelopment inpatient 35-37 weeks postmenstrual age event related potentials (ERP)
Infant Neurodevelopment 4 months corrected age 4 months corrected age visual evoked potentials (VEP)
Milk metabolome 4 months corrected age 4 months corrected gestational age Concentration of untargeted and targeted metabolites
Infant gut microbiome 4 months corrected age 4 months corrected age Microbial diversity of fecal samples
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States