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

Randomized Controlled Trial of Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants: Enhancing Stress Regulation, Neurodevelopment, and Oral Feeding Skills

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.

Inclusion Criteria:

• Born at ≤ 32 weeks gestational age.
• Receiving mother's own milk and/or donor human milk at the time of screening.

Exclusion Criteria:

• Receiving only formula.
• Gastrointestinal defects, i.e., cleft lip or cleft palate.
• Congenital cardiac defects requiring surgery.
• Necrotizing enterocolitis.
• Chromosomal abnormalities.