NCT07216664: M-MILK RCT

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

Recruiting now NA Last updated 20 January 2026

What this trial tests

NA trial testing Multisensory early oral administration of human milk in Infant, Premature, Diseases in 125 participants. Currently enrolling.

Timeline

3 November 2025

Primary endpoint
31 May 2030

31 May 2031

Quick facts

Lead sponsor	Loyola University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	125
Start date	3 November 2025
Primary completion	31 May 2030
Estimated completion	31 May 2031
Sites	2 locations across United States

Drugs / interventions tested

• Multisensory early oral administration of human milk

Conditions studied

• Infant, Premature, Diseases — all drugs for Infant, Premature, Diseases →

Sponsor

Loyola University

Who can join

Adults 23 Weeks to 32 Weeks, any sex, with Infant, Premature, Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Study Protocol for a 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.
   Griffith T, Janusek L, White-Traut R, Green SJ, et al · · 2026 · PMID 41554032 · DOI 10.1177/10998004261418708