Multisensory Early Oral Administration of Human Milk in Preterm Infants
- Conditions
- Infant DevelopmentStress
- Interventions
- Procedure: Multisensory Early Oral Administration of Human Milk (M-MILK)
- Registration Number
- NCT06230848
- Lead Sponsor
- Loyola University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- born between 22 to 28 weeks gestational age and receiving mother's own milk and/or donor milk.
- receiving only formula, oral cavity defects, gastrointestinal defects, chromosomal abnormalities, severe cardiac defects that require surgery, or intraventricular hemorrhage grade III or IV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description M-MILK Multisensory Early Oral Administration of Human Milk (M-MILK) Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
- Primary Outcome Measures
Name Time Method Retention 2 months corrected age Retention will be described by the percentage of post-discharge follow-up surveys completed.
Variability in the Scarf Sign cluster of the Neurobehavioral Assessment of the Preterm Infants score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for scarf sign ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Variability in the percent sleep cluster of the Neurobehavioral Assessment of the Preterm Infants score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for percent sleep ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Acceptability of intervention At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The percentage of parents who rate the intervention as very positive, slightly positive, or acceptable on a 5-point Likert scale.
Variability in the popliteal angle cluster of the Neurobehavioral Assessment of the Preterm Infants score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for popliteal angle ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Variability in the irritability cluster of the Neurobehavioral Assessment of the Preterm Infants score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for irritability ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Variability in the Nursing Child Assessment Satellite Training-Feeding Scale score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The Nursing Child Assessment Satellite Training-Feeding Scale (76 items) consists of six subscales: (a) maternal-sensitivity to cues (range 0 - 16); (b) maternal response to distress (range 0 - 11); (c) maternal social-emotional growth-fostering (range 0 - 14); (d) maternal cognitive growth fostering (range 0 -9); (e) infant clarity of cues (range 0 - 15); and (f) infant responsiveness to caregiver (range 0 - 11), where higher scores indicate better interactions and responses. .
Variability in the motor development & vigor cluster of the Neurobehavioral Assessment of the Preterm Infants score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for motor development \& vigor ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Variability in the quality of cry cluster of the Neurobehavioral Assessment of the Preterm Infants score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for quality of cry ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Feasibility of intervention At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. Determine the feasibility of intervention. M-MILK will be considered feasible if M-MILK is implemented by nurses or parents after every hands-on care and during the beginning of a full gavage feeding at least 50% of the time.
Variability in the alertness and orientation cluster of the Neurobehavioral Assessment of the Preterm Infants score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for alertness and orientation ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Variability in Early Feeding Skill Assessment score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. EFS has 22 items (32-50 weeks PMA), summary scores, 5 subscales: respiratory regulation (range 5 - 15), oral-motor functioning (range 4 - 12), swallowing coordination (range 4 - 12), engagement (range 2 - 6), \& physiologic stability (range 4 - 12), where higher scores indicate better oral feeding skill development.
- Secondary Outcome Measures
Name Time Method Variability in Parent Discharge Readiness score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. Scores range from 44 to 308, where higher scores indicate more parental readiness for discharge.
Breastmilk pumping rate At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The percentage of mothers who report breastmilk pumping at discharge.
Breastfeeding rate At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. The percentage of mothers who report breastfeeding at discharge.
Variability in maternal Edinburgh Postnatal Depression Scale score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. Scores range from 0 to 30, where higher scores indicate greater depressive symptoms
Variability in Parent Stressor Scale: NICU score At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. Scores range from 26 to 130, where higher scores indicate greater parental stress..
Trial Locations
- Locations (1)
Loyola University Chicago
🇺🇸Maywood, Illinois, United States