Clinical trial NCT06230848: Multisensory Early Oral Administration of Human Milk in Preterm Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Stress
Keywords: stress
preterm infants
epigenetics
gut microbiome
parent-infant relationship
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 14
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of intervention
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Acceptability of intervention
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Retention
timeFrame: 2 months corrected age
measure: Variability in the Scarf Sign cluster of the Neurobehavioral Assessment of the Preterm Infants score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in the motor development & vigor cluster of the Neurobehavioral Assessment of the Preterm Infants score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in the popliteal angle cluster of the Neurobehavioral Assessment of the Preterm Infants score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in the alertness and orientation cluster of the Neurobehavioral Assessment of the Preterm Infants score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in the irritability cluster of the Neurobehavioral Assessment of the Preterm Infants score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in the quality of cry cluster of the Neurobehavioral Assessment of the Preterm Infants score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in the percent sleep cluster of the Neurobehavioral Assessment of the Preterm Infants score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in Early Feeding Skill Assessment score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in the Nursing Child Assessment Satellite Training-Feeding Scale score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Secondary outcomes:
measure: Variability in Parent Stressor Scale: NICU score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in Parent Discharge Readiness score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Breastmilk pumping rate
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Breastfeeding rate
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in maternal Edinburgh Postnatal Depression Scale score
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Other outcomes:
measure: Variability in gut microbial community structure and relative abundance of SCFA- and lactate- producing bacteria
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in DNA methylation of NR3C1 promoter
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
measure: Variability in DNA methylation of HSD11B2 promoter
timeFrame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Locations:
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
Study officials:
References: