Multisensory early oral human 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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 23 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | Loyola University Academic / other |
| Locations | 2 sites (Maywood, Illinois and 1 other locations) |
| Trial ID | NCT07216664 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Maywood, Illinois and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.