Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06230848
Other study ID # 217411
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 23, 2023
Est. completion date October 23, 2024

Study information

Verified date January 2024
Source Loyola University
Contact Thao Griffith, PhD
Phone 708-216-5708
Email tgriffith1@luc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date October 23, 2024
Est. primary completion date October 23, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Years to 1 Year
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Multisensory Early Oral Administration of Human Milk (M-MILK)
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.

Locations

Country Name City State
United States Loyola University Chicago Maywood Illinois

Sponsors (1)

Lead Sponsor Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Variability in gut microbial community structure and relative abundance of SCFA- and lactate- producing bacteria Alpha diversity indices will be obtained. Differential abundance individual taxa will be obtained. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Other Variability in DNA methylation of NR3C1 promoter The percent DNAm at the NR3C1 promoters and at each CpG site will be quantified. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Other Variability in DNA methylation of HSD11B2 promoter The percent DNAm at the HSD11B2 promoters and at each CpG site will be quantified. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Feasibility of intervention 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. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Acceptability of intervention The percentage of parents who rate the intervention as very positive, slightly positive, or acceptable on a 5-point Likert scale. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Retention Retention will be described by the percentage of post-discharge follow-up surveys completed. 2 months corrected age
Primary Variability in the Scarf Sign cluster of the Neurobehavioral Assessment of the Preterm Infants score 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. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Variability in the motor development & vigor cluster of the Neurobehavioral Assessment of the Preterm Infants score 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. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Variability in the popliteal angle cluster of the Neurobehavioral Assessment of the Preterm Infants score 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. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Variability in the alertness and orientation cluster of the Neurobehavioral Assessment of the Preterm Infants score 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. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Variability in the irritability cluster of the Neurobehavioral Assessment of the Preterm Infants score 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. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Variability in the quality of cry cluster of the Neurobehavioral Assessment of the Preterm Infants score 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. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Variability in the percent sleep cluster of the Neurobehavioral Assessment of the Preterm Infants score 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. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Variability in Early Feeding Skill Assessment score 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. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Primary Variability in the Nursing Child Assessment Satellite Training-Feeding Scale score 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. . At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Secondary Variability in Parent Stressor Scale: NICU score Scores range from 26 to 130, where higher scores indicate greater parental stress.. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Secondary Variability in Parent Discharge Readiness score Scores range from 44 to 308, where higher scores indicate more parental readiness for discharge. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Secondary Breastmilk pumping rate The percentage of mothers who report breastmilk pumping at discharge. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Secondary Breastfeeding rate The percentage of mothers who report breastfeeding at discharge. At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Secondary Variability in maternal Edinburgh Postnatal Depression Scale score Scores range from 0 to 30, where higher scores indicate greater depressive symptoms At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Recruiting NCT04038190 - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course Phase 2
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Active, not recruiting NCT05998161 - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout N/A
Completed NCT03728062 - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT06405789 - The Effect of Yoga on Mindfulness and Perceived Stress N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT05245409 - Stress, EEG, ECG, and Chiropractic N/A
Completed NCT04722367 - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT06057883 - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females Phase 2
Completed NCT05312749 - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students N/A
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Completed NCT05623826 - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager N/A
Completed NCT04013451 - The Kiss of Kindness Study II N/A