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Study identifier: NCT07216664 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Infant, Premature, Diseases  ·  Sponsor: Loyola University

PhaseNA
Planned participants125
Who can joinAll sexes, 23 Weeks to 32 Weeks
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Thao Griffith, PhD  ·  464-220-9825  ·  tgriffith1@luc.edu

Cara Joyce, PhD  ·  464-220-9521  ·  cjoyce6@luc.edu

Always discuss trial participation with your own doctor first.

Locations (2)

Loyola University ChicagoMaywood, Illinois, United StatesRecruiting
Loyola University Medical CenterMaywood, Illinois, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07216664