Maternal Stress, Milk Composition, and Preterm Neurodevelopment
ConditionPrematurity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28-34
SponsorUniversity of Minnesota
About this trial
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
This trial does not accept healthy volunteersQualifiers
preterm infant born between 25 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
Disqualifiers
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: known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
Trial population
Early preterm infants and their mothers
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Maternal milk production inpatient
total volume (mL)
Time frame
28-35 weeks postmenstrual age2
Maternal milk production 4 months corrected age
total volume (mL)
Time frame
4 months corrected age3
Maternal milk proportion inpatient
Proportion of maternal milk vs donor milk/formula (%)
Time frame
28-35 weeks postmenstrual age4
Maternal milk proportion 4 months corrected age
Proportion of maternal milk vs donor milk/formula (%)
Time frame
4 months corrected ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov