The goal of this clinical trial is to learn if the multisensory early oral administrationof human milk (M-MILK) intervention helps infants who are born younger than 32 weeksgestational age (very preterm infants). The main question that this clinical trial aimsto 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 verypreterm 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.
Not Provided
Other: Multisensory early oral administration of human milk
M-MILK is implemented starting on day 3 of life, during the day shift, after every
hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day.
Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral
feeding initiation. Infants will receive either mother's own milk or donor's milk based
on availability. Infants may receive up to 1 mL of milk each time based on their cues and
responses. The 1 mL volume intake is included as part of their oral caloric intake.
M-MILK is provided by research nurses or parents.
Other Name: M-MILK
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.
Not Provided
Thao Griffith, PhD
464-220-9825
tgriffith1@luc.edu
Cara Joyce, PhD
464-220-9521
cjoyce6@luc.edu
Thao Griffith, PhD, Principal Investigator
Loyola University Chicago