Multisensory early oral human milk for very preterm infants
Official title: 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
Run by Loyola University · NCT07216664 · Data updated 2026-11-12
This test will try whether giving multisensory early oral human milk to babies born before 32 weeks helps their stress response, brain development, and learning to feed by mouth.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 23 Weeks to 32 Weeks |
| Sex | All |
| Enrollment | 125 (estimated) |
| Sponsor | Loyola University Academic / other |
| Locations | 2 sites (Maywood, Illinois and 1 other locations) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | May 31, 2030 |
| Study ends | May 31, 2031 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT07216664 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants born at or before 32 weeks gestation who are receiving mother's own milk and/or donor human milk and are cared for at the participating NICU sites.
✕Probably not a fit
Infants who receive only formula or who have necrotizing enterocolitis, significant gastrointestinal or cardiac malformations requiring surgery, or chromosomal abnormalities are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional study compares a multisensory early oral human milk protocol (M-MILK) plus standard care versus standard care alone in infants born at or before 32 weeks gestation. The M-MILK intervention begins on day 3 of life and is delivered by clinical research nurses up to four times per day during the day shift until infants establish oral feeding. Primary biologic and developmental outcomes include salivary cortisol, DNA methylation of stress-related genes NR3C1 and HSD11B2, measures of neurodevelopment, and oral feeding competence. Infants receiving only formula or with major congenital, gastrointestinal, cardiac, or chromosomal conditions are excluded.
Why it matters
Potential benefit: If successful, M-MILK could lower stress-related hormone activity, support healthier neurodevelopment, and help very preterm infants transition to safe oral feeding sooner.
How similar studies have gone: Related work on early breastmilk exposure and multisensory caregiving has shown promising effects on stress and feeding, but the specific M-MILK protocol is relatively novel and not yet validated in large trials.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Loyola University Chicago
Maywood, Illinois, United States Recruiting -
Loyola University Medical Center
Maywood, Illinois, United States Recruiting
Study contacts
- Principal investigator: Thao Griffith, PhD — Loyola University Chicago
- Study coordinator: Thao Griffith, PhD
- Email: tgriffith1@luc.edu
- Phone: 464-220-9825
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.