Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
Purpose
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.
Condition
- Infant, Premature, Diseases
Eligibility
- Eligible Ages
- Between 23 Weeks and 32 Weeks
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental M-MILK Group |
Infants in the M-MILK group will receive M-MILK intervention and standard of care. 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. |
|
|
No Intervention Control Group |
Infants in the Control group will receive standard of care. |
|
Recruiting Locations
Maywood, Illinois 60153
Maywood, Illinois 60153
More Details
- NCT ID
- NCT07216664
- Status
- Recruiting
- Sponsor
- Loyola University