Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants (NCT07460089) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants
Iraq150 participantsStarted 2026-03-10
Plain-language summary
This study compares three approaches to help premature babies learn to feed by mouth: a special mouth exercise program (called PIOMI), using a pacifier, and standard care. Premature babies often have difficulty feeding because their sucking, swallowing, and breathing are not yet coordinated, which can lead to longer hospital stays. The study will include 150 premature infants born between 26 and 32 weeks of pregnancy at a hospital in Thi Qar. Babies will be randomly placed into one of three groups: one group will receive a many-day mouth exercise program, another will use a pacifier for many days, and the third will receive routine care. We will measure how quickly each baby learns to feed fully by mouth, how long they stay in the hospital, how much weight they gain, and their feeding skills. The results may help improve care for premature babies and reduce the time they spend in the hospital.
Who can participate
Age range
1 Day – 28 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
. \- Preterm infants born at 26-32 weeks of gestational age
. \- Clinically stable (no mechanical ventilation, no major congenital anomalies, no necrotizing enterocolitis)
. \- Birth weight ≥1000 grams
. \- Informed consent obtained from parents or legal guardians
. Neurological impairment affecting sucking ability (e.g., intraventricular hemorrhage grade III or IV, periventricular leukomalacia)
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
1
Time to Achieve Full Oral Feeding
Timeframe: From start of intervention until achievement of full oral feeding (up to hospital discharge, approximately 8 weeks)