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Maternal Stress, Milk, and Preterm Neurodevelopment Study

This study is looking at how stress in mothers of premature babies (born between 28 and 34 weeks) might affect their breast milk and their baby's brain development. Researchers want to see if maternal stress changes breast milk composition and the baby's gut health, and how this relates to the baby's development in the Neonatal Intensive Care Unit (NICU) and at 4 months corrected age (meaning 4 months from their original due date). You might be able to join if you are a mother aged 18-45 with a medically stable premature baby born between 28 and 34 weeks. The study aims to understand if maternal stress impacts how much breast milk is provided, the milk's makeup, and the baby's neurocognitive status. The study is currently unclear on its recruitment status and plans to enroll 120 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatment. It plans to include 120 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure maternal milk production at 28-35 weeks postmenstrual age and at 4 months corrected age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05537454

Maternal Stress, Milk Composition, and Preterm Neurodevelopment

Recruiting
Not specifiedAges 28–34Observational
University of Minnesota
~120 participants
Updated 2025-09-10 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maternal milk production inpatient
Measured over 28-35 weeks postmenstrual age
+12 more outcomes measured

Conditions

Prematurity

Explore related trials

Preterm Birth

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

Emily Nagel, PhD, RD
[email protected]
612-624-9222
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Maternal milk production inpatient28-35 weeks postmenstrual age

    total volume (mL)

  • Maternal milk production 4 months corrected age4 months corrected age

    total volume (mL)

  • Maternal milk proportion inpatient28-35 weeks postmenstrual age

    Proportion of maternal milk vs donor milk/formula (%)

  • Maternal milk proportion 4 months corrected age4 months corrected age

    Proportion of maternal milk vs donor milk/formula (%)

  • Infant Neurodevelopment inpatient35-37 weeks postmenstrual age

    event related potentials (ERP)

  • Infant Neurodevelopment 4 months corrected age4 months corrected age

    event related potentials (ERP)

  • Infant Neurodevelopment 4 months corrected age4 months corrected age

    visual evoked potentials (VEP)

  • Infant gut microbiome inpatient28-35 weeks postmenstrual age

    Microbial diversity of fecal samples

  • Infant gut microbiome 4 months corrected age4 months corrected age

    Microbial diversity of fecal samples

  • Milk microbiome inpatient28-35 weeks postmenstrual age

    Microbial diversity of milk samples

  • Milk microbiome 4 months corrected age4 months corrected age

    Microbial diversity of milk samples

  • Milk metabolome inpatient28-35 weeks postmenstrual age

    Concentration of untargeted and targeted metabolites

  • Milk metabolome 4 months corrected age4 months corrected gestational age

    Concentration of untargeted and targeted metabolites