CompletedNot Applicable

Multisensory Early Oral Administration of Human Milk in Preterm Infants

United States14 participantsStarted 2023-10-23

Plain-language summary

The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation. This study will advance nursing science and practice because it will inform our R01 RCT to examine the efficacy of M-MILK to attenuate adverse effects of early life toxic stress in preterm infants.

Who can participate

Age range

0 Years – 1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * born between 22 to 34 weeks gestational age and receiving mother's own milk and/or donor milk. Exclusion Criteria: * receiving only formula, oral cavity defects, gastrointestinal defects, chromosomal abnormalities, severe cardiac defects that require surgery, or intraventricular hemorrhage grade III or IV

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of Intervention

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Acceptability of Intervention

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Retention

Timeframe: 2 months corrected age

The Scarf Sign Cluster of the Neurobehavioral Assessment of the Preterm Infants Score

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Variability in the Motor Development & Vigor Cluster of the Neurobehavioral Assessment of the Preterm Infants Score

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Popliteal Angle Cluster of the Neurobehavioral Assessment of the Preterm Infants Score

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Trial details

NCT IDNCT06230848

SponsorLoyola University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-23

Results submitted2025-11-21

View on ClinicalTrials.gov More Infant Development trials

Plain-language summary

Who can participate

Age range

0 Years – 1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility of Intervention

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Acceptability of Intervention

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Retention

Timeframe: 2 months corrected age

The Scarf Sign Cluster of the Neurobehavioral Assessment of the Preterm Infants Score

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Variability in the Motor Development & Vigor Cluster of the Neurobehavioral Assessment of the Preterm Infants Score

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Popliteal Angle Cluster of the Neurobehavioral Assessment of the Preterm Infants Score

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.