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

Part of paid clinical trials in Maywood, Illinois.

Sponsor
Loyola University
Study ID
NCT07216664
Status
Recruiting
Apply to this trial

Conditions

  • Infant, Premature, Diseases

Eligibility Criteria

Sex
ALL
Age
23 Weeks - 32 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Multisensory early oral administration of human milk — OTHER
    M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their oral caloric intake. M-MILK is provided by research nurses or parents.

Study Details

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.

Key Dates

Start date
Nov 3, 2025
Status verified
Jan 2026
Primary completion
May 31, 2030
Completion
May 31, 2031

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: M-MILK Group
    Infants in the M-MILK group will receive M-MILK intervention and standard of care. M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their oral caloric intake. M-MILK is provided by research nurses or parents.
  • No Intervention: Control Group
    Infants in the Control group will receive standard of care.

Primary Outcome Measure

Oral feeding Skills: EFS assessment total score at PO Initiation [ Time Frame: Up to 12 weeks after birth. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Loyola University ChicagoMaywoodIllinois60153
Thao Griffith
[email protected]
4642209825
Loyola University Medical CenterMaywoodIllinois60153
Thao Griffith
[email protected]
4642209825

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Loyola University Chicago· Maywood, ILLoyola University Medical Center· Maywood, IL

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