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NCT07216664NARecruiting

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

Loyola University

Start Date

11/3/2025

Completion Date

5/31/2031

Summary

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

OTHER

Multisensory early oral administration of human milk

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Conditions

Infant, Premature, Diseases

Locations

Loyola University Chicago

Maywood, Illinois 60153

United States

Loyola University Medical Center

Maywood, Illinois 60153

United States