Maternal Stress, Milk Composition, and Preterm Neurodevelopment

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05537454
• Other study ID #: SPH-2022-31233
• Status: Recruiting
• Start date: December 9, 2022
• Est. completion date: July 31, 2027

Study information

• Verified date: May 2024
• Source: University of Minnesota
• Contact: Emily Nagel, PhD, RD
• Phone: 616-626-5476
• Email: NICUresearch[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal milk production inpatient	total volume (mL)	28-35 weeks postmenstrual age
Primary	Maternal milk production 4 months corrected age	total volume (mL)	4 months corrected age
Primary	Maternal milk proportion inpatient	Proportion of maternal milk vs donor milk/formula (%)	28-35 weeks postmenstrual age
Primary	Maternal milk proportion 4 months corrected age	Proportion of maternal milk vs donor milk/formula (%)	4 months corrected age
Primary	Infant Neurodevelopment inpatient	event related potentials (ERP)	35-37 weeks postmenstrual age
Primary	Infant Neurodevelopment 4 months corrected age	event related potentials (ERP)	4 months corrected age
Primary	Infant Neurodevelopment 4 months corrected age	visual evoked potentials (VEP)	4 months corrected age
Primary	Infant gut microbiome inpatient	Microbial diversity of fecal samples	28-35 weeks postmenstrual age
Primary	Infant gut microbiome 4 months corrected age	Microbial diversity of fecal samples	4 months corrected age
Primary	Milk microbiome inpatient	Microbial diversity of milk samples	28-35 weeks postmenstrual age
Primary	Milk microbiome 4 months corrected age	Microbial diversity of milk samples	4 months corrected age
Primary	Milk metabolome inpatient	Concentration of untargeted and targeted metabolites	28-35 weeks postmenstrual age
Primary	Milk metabolome 4 months corrected age	Concentration of untargeted and targeted metabolites	4 months corrected gestational age