Recruiting

M-MILK

Sponsor:

Loyola University

Code:

NCT07216664

Conditions

Infant, Premature, Diseases

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Multisensory early oral administration of human milk

Study Details

Brief summary:

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.

Conditions

Infant, Premature, Diseases

Study ID

NCT07216664

Start date

Nov 3, 2025

Status verified date

Jan, 2026

Completion date

May 31, 2031

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Born at ≤ 32 weeks gestational age.
  • Receiving mother's own milk and/or donor human milk at the time of screening.

Exclusion Criteria:

  • Receiving only formula.
  • Gastrointestinal defects, i.e., cleft lip or cleft palate.
  • Congenital cardiac defects requiring surgery.
  • Necrotizing enterocolitis.
  • Chromosomal abnormalities.

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Multisensory early oral administration of human milk

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.

Primary outcome measure

  • Oral feeding Skills: EFS assessment total score at PO Initiation [ Time Frame: Up to 12 weeks after birth. ]
  • Oral Feeding Skills: EFS assessment total score at 36 Weeks PMA [ Time Frame: 36 weeks postmenstrual age. ]

Central Contacts and Locations

Central contacts

Thao Griffith, PhD

464-220-9825tgriffith1@luc.edu

Cara Joyce, PhD

464-220-9521cjoyce6@luc.edu

Locations

Loyola University Chicago

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Thao Griffith

4642209825tgriffith1@luc.edu

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Thao Griffith

4642209825tgriffith1@luc.edu

More Information

Sponsor

Loyola University

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2026-01-20.