Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants
PIOMI
The Effect of the Premature Infant Oral Motor Intervention Versus Pacifier Use in the Transition to Oral Feeding in Preterm Infants
3 other identifiers
interventional
150
1 country
1
Brief 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedStudy Start
First participant enrolled
March 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
CompletedMarch 10, 2026
March 1, 2026
1 month
February 27, 2026
March 6, 2026
Conditions
Keywords
Outcome Measures
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)
From start of intervention until achievement of full oral feeding (up to hospital discharge, approximately 8 weeks)
Study Arms (3)
Premature Infant Oral Motor Intervention (PIOMI) Group
EXPERIMENTALPremature Infant Oral Motor Intervention (PIOMI) Group The PIOMI group is the experimental arm receiving a structured, evidence-based oral motor stimulation program. This standardized intervention is initiated once the infant is medically stable, typically between 29-32 weeks postmenstrual age. It is administered once daily for 7 consecutive days, with each session lasting 5-10 minutes. The protocol includes systematic stimulation of perioral and intraoral structures (cheeks, lips, gums, tongue, and palate) and facilitation of sucking movements. The objective is to enhance oromotor function, improve coordination of sucking-swallowing-breathing, and accelerate the transition to full oral feeding, thereby reducing hospital stay.
Pacifier Use Group
ACTIVE COMPARATORThis group serves as the active comparator arm, receiving non-nutritive sucking (NNS) via a standard pacifier. The intervention is initiated once the infant is medically stable, typically between 29-32 weeks postmenstrual age, consistent with the PIOMI group timeline. Pacifier use is provided 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. The pacifier is offered without additional oral stimulation. The objective is to evaluate the effect of pacifier-based NNS on oral feeding readiness, sucking organization, and transition to full oral feeding compared to the structured PIOMI protocol and routine care. This comparator allows differentiation between passive sucking effects and active oromotor stimulation.
control group
NO INTERVENTIONControl Group (No Intervention) This group serves as the control arm, receiving routine neonatal care without any structured oral motor intervention or protocol-driven pacifier use. Infants in this group receive standard care as per the neonatal intensive care unit (NICU) protocol, including gavage feeding, gradual introduction of oral feeding based on clinical readiness, and routine nursing care. Pacifiers may be used sporadically at the discretion of nursing staff or parents, but not as part of a structured protocol. The objective is to establish a baseline for comparison with the PIOMI and pacifier groups, allowing assessment of the natural progression of oral feeding skills and the specific effects of the active interventions on feeding outcomes, growth, and hospital stay duration.
Interventions
A 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.
Provision 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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al-Habobi Teaching Hospital
Nasiriyah, Thi Qar, Iraq
Related Publications (1)
1- Perin J, Mulick A, Yeung D, Villavicencio F, Lopez G, Strong KL, Prieto-Merino D, Cousens S, Black RE, Liu L. Global, regional, and national causes of under-5 mortality in 2000-19: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet Child Adolesc Health. 2022 Feb;6(2):106-115. doi: 10.1016/S2352-4642(21)00311-4.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zaid W Ajel, PhD, Assoc Prof
University of Baghdad / College of Nursing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- This is an open-label trial. Due to the nature of the behavioral interventions (PIOMI requires active oromotor stimulation, pacifier use is visible, and control receives no intervention), blinding of participants (infants), care providers, and the investigator delivering the interventions is not feasible. However, to minimize detection bias, outcome assessors responsible for evaluating early feeding skills, feeding efficiency, weight gain, and achievement of full oral feeding will be blinded to group allocation. Assessors are not involved in clinical care or intervention delivery and remain unaware of group assignments throughout the study. Data analysts may also be blinded using coded group identifiers. This partial masking strategy ensures objective outcome measurement while acknowledging practical constraints of non-pharmacological trials in preterm infants.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 27, 2026
First Posted
March 10, 2026
Study Start
March 10, 2026
Primary Completion
April 20, 2026
Study Completion
May 30, 2026
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
This study does not plan to share individual participant data (IPD) with other researchers due to the following reasons: * Data Sensitivity: The study involves a vulnerable population (preterm infants), and the informed consent obtained from parents does not include provisions for sharing raw data beyond this research. * Single-Center Context: As a two -center master's thesis conducted in Iraq, the data are context-specific and may not be generalizable to other populations without appropriate validation. * Lack of Infrastructure: No established data repository, resources, or funding are available for anonymizing, storing, or sharing IPD. Confidentiality Concerns: Maintaining participant confidentiality and complying with local ethical regulations take precedence over data sharing. Publication Plans: Aggregate results will be published in peer-reviewed journals and presented at conferences, fulfilling dissemination requirements without sharing individual-level data.