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NCT Number: NCT05537454

Maternal Stress, Milk Composition, and Preterm Neurodevelopment

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

28 week–34 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Emily Nagel, PhD

CONTACT

[email protected]

612-624-9222

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Maternal milk production inpatient

    Time frame: 28-35 weeks postmenstrual age

    total volume (mL)

  2. Maternal milk production 4 months corrected age

    Time frame: 4 months corrected age

    total volume (mL)

  3. Maternal milk proportion inpatient

    Time frame: 28-35 weeks postmenstrual age

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

  4. Maternal milk proportion 4 months corrected age

    Time frame: 4 months corrected age

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

  5. Infant Neurodevelopment inpatient

    Time frame: 35-37 weeks postmenstrual age

    event related potentials (ERP)

  6. Infant Neurodevelopment 4 months corrected age

    Time frame: 4 months corrected age

    event related potentials (ERP)

  7. Infant Neurodevelopment 4 months corrected age

    Time frame: 4 months corrected age

    visual evoked potentials (VEP)

  8. Infant gut microbiome inpatient

    Time frame: 28-35 weeks postmenstrual age

    Microbial diversity of fecal samples

  9. Infant gut microbiome 4 months corrected age

    Time frame: 4 months corrected age

    Microbial diversity of fecal samples

  10. Milk microbiome inpatient

    Time frame: 28-35 weeks postmenstrual age

    Microbial diversity of milk samples

  11. Milk microbiome 4 months corrected age

    Time frame: 4 months corrected age

    Microbial diversity of milk samples

  12. Milk metabolome inpatient

    Time frame: 28-35 weeks postmenstrual age

    Concentration of untargeted and targeted metabolites

  13. Milk metabolome 4 months corrected age

    Time frame: 4 months corrected gestational age

    Concentration of untargeted and targeted metabolites

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Nagel, PhD, RD

CONTACT

[email protected]

612-624-9222

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2030
First posted
Sep 13, 2022
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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