Clinical Trial

Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants

Study acronym: PIOMI
Not Yet Recruiting
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Record status
This record was last updated March 10, 2026 (before its estimated April 20, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07460089
Lead Sponsor University of Baghdad
Conditions Feeding Difficulties, Sucking Behavior, Premature
Enrollment 150 participants
Start Date 2026-03-10
Primary Completion 2026-04-20 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-10