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M-MILK for Very Preterm Infants

This study is looking at whether a treatment called Multisensory Early Oral Administration of Human Milk (M-MILK) helps babies born very early (before 32 weeks of pregnancy). M-MILK involves giving small drops of human milk by syringe during feeding times. Researchers want to see if M-MILK improves how babies handle stress, helps their brain development, and improves their ability to feed by mouth. They will compare babies receiving M-MILK plus standard care to babies receiving only standard care. This study is for babies born at 32 weeks gestational age or earlier who are already receiving human milk. Babies with certain health conditions, like severe heart problems or chromosomal issues, cannot join. The study plans to enroll 125 infants.

Study design
This is an interventional study comparing M-MILK plus standard care to standard care alone. It plans to enroll 125 participants.
What's involved
Participants in the M-MILK group will receive M-MILK up to 4 times a day until they start oral feeding. Oral feeding skills will be assessed up to 12 weeks after birth and at 36 weeks postmenstrual age.
Compensation
Not stated in the trial record.
Follow-up
Oral feeding skills will be assessed up to 12 weeks after birth and again at 36 weeks postmenstrual age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07216664

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

Recruiting
NAAges 23–32InterventionalPrevention
Loyola University
~125 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:Multisensory early oral administration of human milk

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Oral feeding Skills: EFS assessment total score at PO Initiation
Measured over Up to 12 weeks after birth.
+1 more outcome measured

Conditions

Infant, Premature, Diseases

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Premature infant

NCT07216664

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Loyola University Chicago

    Maywood, Illinoisstudy coordinator listed

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Thao Griffith, PhD · PRINCIPAL_INVESTIGATOR · Loyola University Chicago

Who to contact

Thao Griffith, PhD
[email protected]
464-220-9825
Email the study team

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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.

What this trial measures

  • Oral feeding Skills: EFS assessment total score at PO InitiationUp to 12 weeks after birth.

    We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.

  • Oral Feeding Skills: EFS assessment total score at 36 Weeks PMA36 weeks postmenstrual age.

    We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at 36 weeks post-menstrual age (PMA). The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.