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Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants

Study acronym: M-MILK RCT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v3
  2. Secondary endpoints: 41 to 19
    • Eligibility criteria shortened, about 2 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants). The main question that this clinical trial aims to answer is: Does M-MILK improve stress regulation, support optimal neurodevelopment, and promote competent oral feeding skills in very preterm infants? Researchers will compare M-MILK to the standard of care to see if M-MILK helps very preterm infants. Specifically, researchers will compare the differences in: * Cortisol levels * DNA methylation of the two stress related genes (NR3C1 and HSD11B2) * Neurodevelopment * Oral feeding skills Participants in the M-MILK group will receive standard of care plus M-MILK intervention, which starts on day 3 of life and continues until they begin their oral feeding. M-MILK will be provided by clinical research nurses, during the day shift, up to 4 times a day. Participants in the standard of care group will continue to receive their usual care.
Trial Details
NCT Number NCT07216664
Lead Sponsor Loyola University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Rush University Medical Center
Conditions
(from sponsor)		 Infant, Premature, Diseases
Related terms Infant, Premature, Diseases
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov