NCT07216664
Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
- Thao Griffith, PhD - Role: CONTACT - Phone: 464-220-9825 - Email: tgriffith1@luc.edu
- Cara Joyce, PhD - Role: CONTACT - Phone: 464-220-9521 - Email: cjoyce6@luc.edu
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RECRUITING
NCT07216664
INTERVENTIONAL
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.
Infant, Premature, Diseases
- PREVENTION
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- Type: OTHER
- Name: Multisensory early oral administration of human milk
- Description: 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.
- Arm Group Labels: M-MILK Group
- Loyola University