About this trial
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.
Eligibility criteria
Qualifiers
Born at ≤ 32 weeks gestational age.
Receiving mother's own milk and/or donor human milk at the time of screening.
Disqualifiers
Receiving only formula.
Gastrointestinal defects, i.e., cleft lip or cleft palate.
Congenital cardiac defects requiring surgery.
Necrotizing enterocolitis.
Trial design
Treatments tested in this trial
- Multisensory early oral administration of human milk
Treatment groups
Sponsors and collaborators
Loyola University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Rush University Medical Center
Collaborator