Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants
Starting soon · Not applicable
Conditions studied: Feeding Difficulties, Sucking Behavior, Premature
In brief
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.
Key facts
- Study ID
- NCT07460089
- Run by
- University of Baghdad
- People needed
- 150
- Starts
- 2026-03-10
- Expected to finish
- 2026-05-30
- Last updated by the study team
- 2026-03-10
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- - 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
You may not qualify if…
- Orofacial malformations (e.g., cleft lip, cleft palate)
- Neurological impairment affecting sucking ability (e.g., intraventricular hemorrhage grade III or IV, periventricular leukomalacia)
- Infants who received any prior structured oral motor intervention
- Major congenital anomalies or genetic syndromes affecting feeding or development
- Infants requiring surgical interventions during the study period
- Lack of parental consent
Where it is running
- Al-Habobi Teaching Hospital — Nasiriyah, Thi Qar, Iraq
Full record on ClinicalTrials.gov
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