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Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
NCT07216664 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07216664
The ClinicalTrials.gov registry entry for NCT07216664 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loyola University, which has 57 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07216664 reports 2 study locations spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07216664?
The interventions under investigation include: Multisensory early oral administration of human milk (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07216664?
This trial is sponsored by Loyola University, which has 57 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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