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
RECRUITING
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
More than 60,000 infants are born between 22 to 32 weeks gestation age annually in the US. Approximately 11% of them develop comorbidities. During NICU hospitalization, preterm infants inevitably endure early life toxic stress without adequate protective buffers. Early life toxic stress results in adverse epigenetic modifications of glucocorticoid-related genes and dysbiosis, impairing neurodevelopment. These adversities further exacerbate the risk of comorbidities and inappropriate brain development during sensitive periods of neuroplasticity. Adverse epigenetic modifications and dysbiosis may set a life-long trajectory of risk for chronic health conditions. It is a clinical and scientific priority to test an early NICU intervention to attenuate stress-related adverse epigenetic modifications and dysbiosis. Human milk influences the structure and relative abundance of healthy gut bacteria and neurodevelopment. Maternal nurturing, e.g., licking and grooming (in rodents), and breastfeeding and touch (in humans), promotes neurodevelopment, reduces stress, and reverses stress-related epigenetic modifications. The multisensory early oral administration of human milk (M-MILK) intervention is designed to provide an enjoyable and nurturing experience for infants, through a safe and consistent infant-guided provision of human milk droplets, given orally as early as 22 weeks postmenstrual age. M-MILK is implemented from day 3 of life, after every hands-on care, and during the beginning of a full gavage feeding. We propose the M-MILK pilot randomized controlled trial (RCT): a 2-group (N = 12, 6 per group), parallel, and longitudinal design in preterm infants who are born between 22 to 28 weeks gestational age. The aims of this pilot are to determine the feasibility and acceptability of the 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 28 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: PROCEDURE
- Name: Multisensory Early Oral Administration of Human Milk (M-MILK)
- Description: M-MILK is implemented as droplets, at day 3 of life, after every hands-on care, and during the beginning of a full gavage feeding. The infant may be supportively positioned in bed, held skin-to-skin by caregiver, or held/cradled by nurse or caregiver. The nurse draws up 1 mL of milk into the 1-mL syringe from a prepared bottle or enteral feeding syringe. The nurse then proceeds to implement M-MILK while observing the infant's responses closely. The nurse talks to the infant with a soft calm voice while providing gentle touch throughout the intervention. The nurse begins M-MILK by first placing 1-2 drops of milk onto the infant's upper lip, allowing the infant to feel and smell the milk. The nurse gently strokes the infant's lips with a pacifier/swab or infant's fingers. M-MILK will be provided based on infants' responses and cues. M-MILK is concluded if the infant is no longer engaged or has finished the 1 mL of milk.
- Arm Group Labels: M-MILK
- Loyola University