NCT05537454 Maternal Stress, Milk Composition, and Preterm Neurodevelopment
| NCT ID | NCT05537454 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Prematurity |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-12-09 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2022-12-09 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05537454 clinical trial?
This trial is open to participants of all sexes, aged 28 Weeks or older, up to 34 Weeks, studying Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05537454 currently recruiting?
Yes, NCT05537454 is actively recruiting participants. Contact the research team at NICUSTRESSstudy@umn.edu for enrollment information.
Where is the NCT05537454 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05537454 clinical trial?
NCT05537454 is sponsored by University of Minnesota. The trial plans to enroll 120 participants.