Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants

The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants). The main question that this clinical trial aims to answer is: Does M-MILK improve stress regulation, support optimal neurodevelopment, and promote competent oral feeding skills in very preterm infants? Researchers will compare M-MILK to the standard of care to see if M-MILK helps very preterm infants. Specifically, researchers will compare the differences in: * Cortisol levels * DNA methylation of the two stress related genes (NR3C1 and HSD11B2) * Neurodevelopment * Oral feeding skills Participants in the M-MILK group will receive standard of care plus M-MILK intervention, which starts on day 3 of life and continues until they begin their oral feeding. M-MILK will be provided by clinical research nurses, during the day shift, up to 4 times a day. Participants in the standard of care group will continue to receive their usual care.

NCT Number	NCT07216664
Lead Sponsor	Loyola University Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Rush University Medical Center
Conditions	Infant, Premature, Diseases
Enrollment	125 participants
Start Date	2025-11-03
Primary Completion	2030-05-31 (estimated)
Study Completion	2031-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-20