Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06230848
Study type Interventional
Source Loyola University
Contact Thao Griffith, PhD
Phone 708-216-5708
Email tgriffith1@luc.edu
Status Recruiting
Phase N/A
Start date October 23, 2023
Completion date October 23, 2024

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