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

Recruiting now · Not applicable

Conditions studied: Infant, Premature, Diseases

In brief

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.

Key facts

Study ID

NCT07216664

Run by

Loyola University

People needed

125

Starts

2025-11-03

Expected to finish

2031-05-31

Last updated by the study team

2026-01-20

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Loyola University Chicago — Maywood, Illinois, United States (enrolling)
• Loyola University Medical Center — Maywood, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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