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NCT07216664 · ClinicalTrials.gov registry record · NA
Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
A NA study of Infant, Premature, Diseases, sponsored by Loyola University.
- Recruiting
- Registry status
- NA
- Development phase
- 125
- Enrollment target
- 2
- Study locations
NCT07216664: Recruiting NA study of Infant, Premature, Diseases, sponsored by Loyola University.
NCT07216664 is a NA study of Infant, Premature, Diseases that is actively recruiting participants, run by Loyola University. The registered enrollment target is 125 participants, below the 184-participant average among 5 other Infant, Premature, Diseases trials with a reported enrollment target (32% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07216664, a NA study of Infant, Premature, Diseases, is actively recruiting participants, sponsored by Loyola University.
- RECRUITING
- Registry status
- NA
- Development phase
- 125 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Multisensory early oral administration of human milk
Study Locations (2)
Illinois
- Loyola University Chicago - Maywood
- Loyola University Medical Center - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2025-11-03 |
| Est. Completion | 2031-05-31 |
| Phase | NA |
What NCT07216664 shows while recruiting
NCT07216664 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 184-participant average among 5 other Infant, Premature, Diseases trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Infant, Premature, Diseases appearing as the primary indexed condition, and to 1 intervention - of which Multisensory early oral administration of human milk is the first listed.
NCT07216664 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT07216664 about?
NCT07216664 is a clinical study titled "Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants". 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 str...
What is the current status of trial NCT07216664?
This trial is currently recruiting. It is a NA study. The enrollment target is 125 participants. The study started on 2025-11-03. Estimated completion is 2031-05-31.
What conditions does trial NCT07216664 study?
This clinical trial studies the following conditions: Infant, Premature, Diseases.
What interventions are being tested in trial NCT07216664?
The interventions under investigation include: Multisensory early oral administration of human milk (OTHER).
Who is sponsoring clinical trial NCT07216664?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07216664 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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