UnknownNot Applicable

Oral Motor Intervention to Preterms by Their Mothers

Turkey (Türkiye)42 participantsStarted 2024-01-10

Plain-language summary

Babies who have been discharged from the neonatal intensive care unit and have difficulty in oral feeding will be identified. Oral Motor Intervention (PIOMI) will be taught to the mothers of these babies and asked to practice. As a result of this application, the change in oral feeding skills in babies and its effect on mother-infant bonding will be evaluated.

Who can participate

Age range

90 Days

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: * Participation in the study is accepted by the family * PIOMI can be applied and whose clinical condition is stable, * Born earlier than 37 weeks, * Those who have not been diagnosed with any disorder in swallowing functions, * Without congenital anomalies and systemic diseases, * Vital signs are stable, * Babies without congenital anomalies or serious complications Exclusion Criteria: * Participation in the study is not accepted by their family, * Those with congenital anomalies and systemic diseases. * Those who have been diagnosed with swallowing disorder, * Those with congenital disorders or birth trauma, * Diagnosed with severe asphyxia, * Those with intraventricular bleeding, * Those with Neonatal Abstinence Syndrome, * Those with Fetal Alcohol Syndrome, * Babies connected to a ventilator

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

The LATCH Breastfeeding Assessment Tool (Latch Audible Swallowing, Type of Nipple, Comfort of Breast/Nipple, H-Hold/ Position)

Timeframe: 0, 7. day, 14. day

Preterm Infant Oral Feeding Readiness Assessment (PIOFRA/ POFRAS)

Timeframe: 0, 7. day, 14. day

Trial details

NCT IDNCT06194513

SponsorMarmara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-30

Contact for this trial

Aylin Demirci, PT

+905423228612 fzt.aylindemirci@gmail.com

View on ClinicalTrials.gov More Premature trials