Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT05537454

Conditions

Prematurity

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Prematurity

Study ID

NCT05537454

Start date

Dec 9, 2022

Status verified date

Sep, 2025

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Maternal milk production inpatient [ Time Frame: 28-35 weeks postmenstrual age ]
  • Maternal milk production 4 months corrected age [ Time Frame: 4 months corrected age ]
  • Maternal milk proportion inpatient [ Time Frame: 28-35 weeks postmenstrual age ]
  • Maternal milk proportion 4 months corrected age [ Time Frame: 4 months corrected age ]
  • Infant Neurodevelopment inpatient [ Time Frame: 35-37 weeks postmenstrual age ]
  • Infant Neurodevelopment 4 months corrected age [ Time Frame: 4 months corrected age ]
  • Infant Neurodevelopment 4 months corrected age [ Time Frame: 4 months corrected age ]
  • Infant gut microbiome inpatient [ Time Frame: 28-35 weeks postmenstrual age ]
  • Infant gut microbiome 4 months corrected age [ Time Frame: 4 months corrected age ]
  • Milk microbiome inpatient [ Time Frame: 28-35 weeks postmenstrual age ]
  • Milk microbiome 4 months corrected age [ Time Frame: 4 months corrected age ]
  • Milk metabolome inpatient [ Time Frame: 28-35 weeks postmenstrual age ]
  • Milk metabolome 4 months corrected age [ Time Frame: 4 months corrected gestational age ]

Central Contacts and Locations

Central contacts

Emily Nagel, PhD, RD

612-624-9222NICUSTRESSstudy@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Emily Nagel, PhD

612-624-9222NICUSTRESSstudy@umn.du

More Information

Sponsor

University of Minnesota

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-09-10.