Maternal Stress, Milk Composition, and Preterm Neurodevelopment
Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedStudy Start
First participant enrolled
December 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
September 10, 2025
September 1, 2025
4.6 years
September 1, 2022
September 9, 2025
Conditions
Outcome Measures
Primary Outcomes (13)
Maternal milk production inpatient
total volume (mL)
28-35 weeks postmenstrual age
Maternal milk production 4 months corrected age
total volume (mL)
4 months corrected age
Maternal milk proportion inpatient
Proportion of maternal milk vs donor milk/formula (%)
28-35 weeks postmenstrual age
Maternal milk proportion 4 months corrected age
Proportion of maternal milk vs donor milk/formula (%)
4 months corrected age
Infant Neurodevelopment inpatient
event related potentials (ERP)
35-37 weeks postmenstrual age
Infant Neurodevelopment 4 months corrected age
event related potentials (ERP)
4 months corrected age
Infant Neurodevelopment 4 months corrected age
visual evoked potentials (VEP)
4 months corrected age
Infant gut microbiome inpatient
Microbial diversity of fecal samples
28-35 weeks postmenstrual age
Infant gut microbiome 4 months corrected age
Microbial diversity of fecal samples
4 months corrected age
Milk microbiome inpatient
Microbial diversity of milk samples
28-35 weeks postmenstrual age
Milk microbiome 4 months corrected age
Microbial diversity of milk samples
4 months corrected age
Milk metabolome inpatient
Concentration of untargeted and targeted metabolites
28-35 weeks postmenstrual age
Milk metabolome 4 months corrected age
Concentration of untargeted and targeted metabolites
4 months corrected gestational age
Eligibility Criteria
Early preterm infants and their mothers
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55414, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2022
First Posted
September 13, 2022
Study Start
December 9, 2022
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2030
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be made available to other researchers no later than the acceptance for publication of the main findings from the final dataset. Depending on the volume of data requests from external researchers, a long term data sharing and preservation plan may be used to store and make publicly accessible the data beyond the life of the project.
Deidentified data upon request