Actively Recruiting
Led by Loyola University · Updated on 2026-01-20
125
Participants Needed
2
Research Sites
52 weeks
Total Duration
L
Loyola University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
This research aims to find out if the multisensory early oral administration of human milk (M-MILK) helps very preterm infants born before 32 weeks gestational age. The study will evaluate whether M-MILK can improve stress regulation, support healthy brain development, and enhance oral feeding skills compared to standard care. Researchers will measure factors like cortisol levels, DNA changes in stress-related genes, neurodevelopment, and feeding abilities in these infants. Participants will be randomly assigned to one of two groups. Infants in the M-MILK group will receive the M-MILK intervention and standard care starting on day 3 of life during the day shift, up to four times daily. M-MILK is given in small amounts via a syringe, using either mother's milk or donor milk, based on availability, and continues until the infant begins oral feeding. The control group will receive standard care without M-MILK. During the study, infants will be monitored for oral feeding skills using the Early Feeding Skills (EFS) assessment up to 12 weeks after birth and again at 36 weeks postmenstrual age. Researchers will also measure stress regulation through salivary cortisol and DNA methylation tests, and assess neurodevelopment with detailed neurological and behavioral scores at 36 weeks postmenstrual age. This comprehensive follow-up aims to capture the effects of M-MILK on early development and feeding in very preterm infants.
CONDITIONS
Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From day 3 of life until oral feeding initiation
Participants in the M-MILK group receive multisensory early oral administration of human milk starting on day 3 of life, given during the day shift after hands-on care and up to 4 times a day. This continues until oral feeding initiation. Participants in the control group receive standard of care.
Daily visits during treatment period
Duration - Up to 12 weeks after birth to 36 weeks postmenstrual age
Participants are assessed for oral feeding skills, stress regulation, and neurodevelopmental outcomes up to 36 weeks postmenstrual age.
Approximately 2 visits up to 36 weeks postmenstrual age
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
T
Thao Griffith, PhD
C
Cara Joyce, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Thao Griffith, Linda Janusek, Rosemary White-Traut...
https://pubmed.ncbi.nlm.nih.gov/41554032