Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorUniversity of Baghdad
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Premature Infant Oral Motor Intervention (PIOMI)
BehavioralA structured, evidence-based protocol of perioral and intraoral stimulation administered once daily for 7 consecutive days (5-10 minutes per session). The protocol includes systematic stimulation of the cheeks, lips, gums, tongue, and palate, followed by facilitation of sucking movements. The intervention is initiated once the infant is medically stable (typically 29-32 weeks postmenstrual age) to enhance oromotor function, improve coordination of sucking-swallowing-breathing, and accelerate the transition to full oral feeding.
Pacifier Use (Non-Nutritive Sucking)
DeviceProvision of a standard silicone pacifier for non-nutritive sucking. The pacifier is offered during gavage feeding sessions and at times when the infant is awake and calm, for approximately 5-10 minutes per session, once daily for 7 consecutive days. This intervention is initiated once the infant is medically stable (typically 29-32 weeks postmenstrual age) and is provided without any additional structured oral stimulation. The objective is to evaluate the effect of passive sucking on oral feeding readiness and organization.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Premature Infant Oral Motor Intervention (PIOMI) GroupExperimental treatment 1 intervention
Group B: Pacifier Use GroupActive comparator 1 intervention
Group C: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Time to Achieve Full Oral Feeding
Time to Achieve Full Oral Feeding Measure Description: The number of days from the start of the intervention to the first 24-hour period of exclusive oral feeding (defined as consuming ≥120 mL/kg/day without tube supplementation). Time Frame: From start of intervention until achievement of full oral feeding (up to hospital discharge, approximately 8 weeks)
Time frame
From start of intervention until achievement of full oral feeding (up to hospital discharge, approximately 8 weeks)Sponsors and contacts
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Source ClinicalTrials.gov
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