Exploring how maternal stress affects breastmilk and preterm infant development

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the relationship between maternal stress, the composition of breastmilk, and neurodevelopmental outcomes in preterm infants. Mothers of infants born between 28 to 34 weeks of gestation will be recruited to assess how variations in maternal stress influence milk volume and quality, as well as the cognitive development of their infants at NICU discharge and at four months corrected age. The study will also involve collecting and analyzing maternal milk and infant fecal samples to explore the impact of maternal stress on gut microbiome and metabolomic profiles. The overarching goal is to enhance neurodevelopmental health for preterm infants by strengthening the mother-milk-infant connection.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Emily Nagel, PhD, RD
• Email: NICUSTRESSstudy@umn.edu
• Phone: 612-624-9222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.