Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Loyola University

Collaborating Sponsors:

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

Rush University Medical Center

Conditions:

Infant, Premature, Diseases

Eligibility:

All Genders

23-32 years

Phase:

NA

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 pre...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

November 3 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 31 2031

Estimated Enrollment :

125 Patients enrolled

Trial Details

Trial ID

NCT07216664

Start Date

November 3 2025

End Date

May 31 2031

Last Update

October 15 2025

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