NCT06230848
Multisensory Early Oral Administration of Human Milk in Preterm Infants
- Thao Griffith, PhD - Role: CONTACT - Phone: 708-216-5708 - Email: tgriffith1@luc.edu
NA
COMPLETED
NCT06230848
INTERVENTIONAL
Multisensory Early Oral Administration of Human Milk in Preterm Infants to Attenuate Early Life Toxic Stress on Epigenetic Modifications and Dysbiosis: Randomized Controlled Trial Pilot Study
The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation. This study will advance nursing science and practice because it will inform our R01 RCT to examine the efficacy of M-MILK to attenuate adverse effects of early life toxic stress in preterm infants.
Inclusion Criteria:
* born between 22 to 34 weeks gestational age and receiving mother's own milk and/or donor milk.
Exclusion Criteria:
* receiving only formula, oral cavity defects, gastrointestinal defects, chromosomal abnormalities, severe cardiac defects that require surgery, or intraventricular hemorrhage grade III or IV
Infant Development
Stress
- TREATMENT
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- Type: OTHER
- Name: Multisensory Early Oral Administration of Human Milk (M-MILK)
- Description: M-MILK is implemented starting on day 3 of life, after every hands-on care, during the beginning of a full gavage feeding. 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 nurses or parents.
- Arm Group Labels: M-MILK
- Loyola University