Condition: Infant, Premature, Diseases · Sponsor: Loyola University
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.
Thao Griffith, PhD · 464-220-9825 · tgriffith1@luc.edu
Cara Joyce, PhD · 464-220-9521 · cjoyce6@luc.edu
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| Loyola University Chicago | Maywood, Illinois, United States | Recruiting |
| Loyola University Medical Center | Maywood, Illinois, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07216664