Clinical trial NCT05537454: Maternal Stress, Milk Composition, and Preterm Neurodevelopment
Official title: Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prematurity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early preterm infants and their mothers

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.

Detailed 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.

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

Primary outcomes:
measure: Maternal milk production inpatient
timeFrame: 28-35 weeks postmenstrual age
measure: Maternal milk production 4 months corrected age
timeFrame: 4 months corrected age
measure: Maternal milk proportion inpatient
timeFrame: 28-35 weeks postmenstrual age
measure: Maternal milk proportion 4 months corrected age
timeFrame: 4 months corrected age
measure: Infant Neurodevelopment inpatient
timeFrame: 35-37 weeks postmenstrual age
measure: Infant Neurodevelopment 4 months corrected age
timeFrame: 4 months corrected age
measure: Infant Neurodevelopment 4 months corrected age
timeFrame: 4 months corrected age
measure: Infant gut microbiome inpatient
timeFrame: 28-35 weeks postmenstrual age
measure: Infant gut microbiome 4 months corrected age
timeFrame: 4 months corrected age
measure: Milk microbiome inpatient
timeFrame: 28-35 weeks postmenstrual age
measure: Milk microbiome 4 months corrected age
timeFrame: 4 months corrected age
measure: Milk metabolome inpatient
timeFrame: 28-35 weeks postmenstrual age
measure: Milk metabolome 4 months corrected age
timeFrame: 4 months corrected gestational age
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: