Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230848
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-05
Brief Title:
Multisensory Early Oral Administration of Human Milk in Preterm Infants
Sponsor:
Loyola University
Organization:
Loyola University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M-MILK
Brief Summary:
More than 60000 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 eg 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None