Actively Recruiting
Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes in Preterm Infants
Led by University of Minnesota · Updated on 2025-09-10
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how maternal stress affects breastmilk composition, feeding outcomes, and neurodevelopment in preterm infants born between 28 and 34 weeks of gestation. The study aims to understand how stress in mothers relates to the amount of milk given and the infant's neurocognitive status at NICU discharge and at 4 months corrected age. It also explores whether stress influences the metabolomic and microbiome profiles of the infant's gut and the milk, and how these differences relate to infant neurodevelopment. Mothers and their preterm infants will be recruited to collect maternal milk and infant fecal samples for detailed analyses. The study will observe the volume and proportion of maternal milk provided during the NICU stay (28 to 35 weeks postmenstrual age) and again at 4 months corrected age. Infant neurodevelopment and gut microbiome will be assessed at NICU discharge (35 to 37 weeks postmenstrual age) and at 4 months corrected age. The study does not involve any interventions but follows these infants and mothers over these time periods. Participants will be involved in sample collection and monitoring during their NICU stay and at 4 months corrected age. Researchers will measure maternal milk production, milk composition, infant neurodevelopment, and gut microbiome at specific timepoints. Mothers and infants will be assessed for feeding outcomes and neurocognitive status, with data collected to better understand the mother-milk-infant relationship and its impact on infant health. The study is observational, and participant involvement lasts through the NICU hospitalization and follow-up at 4 months corrected age.
CONDITIONS
Brief Title
Maternal Stress, Milk Composition, and Preterm Neurodevelopment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infant born between 28 0/7 and 34 6/7 weeks' gestation who is medically stable for study procedures
- Mother of preterm infant meeting criteria and aged 18 to 45 years at time of delivery
You will not qualify if you...
- Infants with major congenital anomalies, anticipated death, positive blood culture at birth, hypoxic ischemic encephalopathy, grade IV intraventricular hemorrhage, or planned transfer of care before discharge (35-37 weeks postmenstrual age)
- Mothers with alcohol consumption greater than 1 drink per week or any tobacco use during pregnancy
- Mothers with known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding or growth
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From 28 weeks postmenstrual age to 4 months corrected age
Participants are observed to assess maternal stress, milk production, infant neurodevelopment, and biological samples during the NICU stay and at 4 months corrected age.
Visits during NICU stay and at 4 months corrected age
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
E
Emily Nagel, PhD, RD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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