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

NCT ID: NCT07216664

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-03
• Study Completion Date: 2031-05-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multisensory early oral administration of human milk

Intervention Type: 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.

Control Group

Infants in the Control group will receive standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: OTHER

Other Intervention Names

M-MILK

Eligibility Criteria

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.

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: collaborator

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thao Griffith, PhD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Chicago

Locations

Loyola University Chicago

Maywood, Illinois, United States

Site Status: RECRUITING

Loyola University Medical Center

Maywood, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Thao Griffith, PhD

Role: CONTACT

tgriffith1@luc.edu

464-220-9825

Cara Joyce, PhD

Role: CONTACT

cjoyce6@luc.edu

464-220-9521

Facility Contacts

Thao Griffith

Role: primary

tgriffith1@luc.edu

4642209825

Thao Griffith

Role: primary

tgriffith1@luc.edu

4642209825

Other Identifiers

218601

Identifier Type: -

Identifier Source: org_study_id