Actively Recruiting
Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
Led by Loyola University · Updated on 2026-01-20
125
Participants Needed
2
Research Sites
290 weeks
Total Duration
On this page
Sponsors
L
Loyola University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born at 6 32 weeks gestational age
- Receiving mother's own milk and/or donor human milk at the time of screening
You will not qualify if you...
- Receiving only formula
- Gastrointestinal defects such as cleft lip or cleft palate
- Congenital cardiac defects requiring surgery
- Necrotizing enterocolitis
- Chromosomal abnormalities
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Loyola University Chicago
Maywood, Illinois, United States, 60153
Actively Recruiting
2
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
Research Team
T
Thao Griffith, PhD
CONTACT
C
Cara Joyce, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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