RecruitingNot ApplicableNCT07216664

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

Sponsor

Loyola University

Enrollment

125 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

Infant, Premature, Diseases

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

Min Age: 23 WeeksMax Age: 32 Weeks

Inclusion Criteria2

Born at ≤ 32 weeks gestational age.
Receiving mother's own milk and/or donor human milk at the time of screening.

Exclusion Criteria5

Receiving only formula.
Gastrointestinal defects, i.e., cleft lip or cleft palate.
Congenital cardiac defects requiring surgery.
Necrotizing enterocolitis.
Chromosomal abnormalities.

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Interventions

OTHERMultisensory early oral administration of human milk

M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their oral caloric intake. M-MILK is provided by research nurses or parents.