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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age23-32
SponsorLoyola University

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

125 Participants
are divided into 2 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