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Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
Randomized Controlled Trial of Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants: Enhancing Stress Regulation, Neurodevelopment, and Oral Feeding Skills
Who can join
23 Weeks – 32 Weeks · All sexes
Full eligibility criteria
Inclusion Criteria: * Born at ≤ 32 weeks gestational age. * Receiving mother's own milk and/or donor human milk at the time of screening. Exclusion Criteria: * Receiving only formula. * Gastrointestinal defects, i.e., cleft lip or cleft palate. * Congenital cardiac defects requiring surgery. * Necrotizing enterocolitis. * Chromosomal abnormalities.
About the study
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.
What is being tested
- Multisensory early oral administration of human milk (other)
Sponsor: Loyola University · Participants: 125 · Started: Nov 3, 2025
Contact the study team
- Thao Griffith, PhD · Phone: 464-220-9825
- Cara Joyce, PhD · Phone: 464-220-9521
Official record on ClinicalTrials.gov — NCT07216664
Locations in the U.S.
| Illinois | Loyola University Chicago, Maywood Loyola University Medical Center, Maywood |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.