Exploring how maternal stress affects breastmilk and preterm infant development
Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes
University of Minnesota · NCT05537454
This study looks at how stress in mothers affects the quality of their breastmilk and the development of their preterm babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 28 Weeks to 34 Weeks |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05537454 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include mothers aged 18 to 45 with medically stable preterm infants born between 28 and 34 weeks of gestation.
Not a fit: Patients who may not benefit include those with major congenital anomalies or significant health issues affecting infant feeding and growth.
Why it matters
Potential benefit: If successful, this study could lead to improved feeding strategies and neurodevelopmental outcomes for preterm infants.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated that maternal factors can significantly influence infant health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Study coordinator: Emily Nagel, PhD, RD
- Email: NICUSTRESSstudy@umn.edu
- Phone: 612-624-9222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prematurity