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Maternal Stress, Milk Composition, and Preterm Neurodevelopment

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05537454
Enrollment
120
Registered
2022-09-13
Start date
2022-12-09
Completion date
2030-07-31
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

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.

Interventions

None listed

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 34 Weeks
Healthy volunteers
No

Inclusion criteria

* preterm infant born between 25 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: known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth

Design outcomes

Primary

MeasureTime frameDescription
Maternal milk production inpatient28-35 weeks postmenstrual agetotal volume (mL)
Maternal milk production 4 months corrected age4 months corrected agetotal volume (mL)
Maternal milk proportion inpatient28-35 weeks postmenstrual ageProportion of maternal milk vs donor milk/formula (%)
Maternal milk proportion 4 months corrected age4 months corrected ageProportion of maternal milk vs donor milk/formula (%)
Infant Neurodevelopment inpatient35-37 weeks postmenstrual ageevent related potentials (ERP)
Infant Neurodevelopment 4 months corrected age4 months corrected ageevent related potentials (ERP)
Infant gut microbiome inpatient28-35 weeks postmenstrual ageMicrobial diversity of fecal samples
Milk microbiome inpatient28-35 weeks postmenstrual ageMicrobial diversity of milk samples
Milk microbiome 4 months corrected age4 months corrected ageMicrobial diversity of milk samples
Milk metabolome inpatient28-35 weeks postmenstrual ageConcentration of untargeted and targeted metabolites
Milk metabolome 4 months corrected age4 months corrected gestational ageConcentration of untargeted and targeted metabolites

Countries

United States

Contacts

CONTACTEmily Nagel, PhD, RD
NICUSTRESSstudy@umn.edu612-624-9222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026