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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature; Sucking Behavior; Feeding Difficulties
• Intervention / Treatment: Behavioral: Premature Infant Oral Motor Intervention (PIOMI); Device: Pacifier Use (Non-Nutritive Sucking)

Detailed Description

Detailed Description:

Preterm birth, defined as delivery before 37 weeks of gestation, affects approximately 10% of live births worldwide and constitutes a major public health challenge. One of the most critical milestones for preterm infants in the neonatal intensive care unit (NICU) is the acquisition of safe and efficient oral feeding. This skill requires coordinated sucking, swallowing, and breathing - a neurodevelopmental process that typically matures only after 34-36 weeks postmenstrual age. Delayed attainment of full oral feeding prolongs hospitalization, increases healthcare costs, and exposes infants to risks such as nosocomial infections and parental psychological distress (Perin et al., 2022; Ibrahim et al., 2024).

The theoretical framework underpinning this study is the "experience-dependent neuroplasticity" model, which posits that structured sensorimotor experiences can accelerate neural pathway development. The Premature Infant Oral Motor Intervention (PIOMI) is a structured, evidence-based protocol designed to provide such experience. It consists of gentle stimulation of the perioral and intraoral structures, including cheeks, lips, gums, tongue, and palate, followed by facilitation of non-nutritive sucking movements. The intervention is delivered in eight sequential steps: (1) cheek C-stretch, (2) lip roll, (3) lip stretch, (4) gum massage, (5) lateral tongue stretch, (6) mid-tongue and palate massage, (7) suck reflex stimulation, and (8) non-nutritive sucking. Each session lasts 5-10 minutes, performed with the infant in a midline chin-tuck position under controlled environmental conditions (dim light, minimal noise). Trained nurses monitor stress cues throughout the procedure to ensure safety. Previous studies have reported that PIOMI may shorten the time to independent oral feeding by 6-13 days and improve weight gain (Thabet & Sayed, 2021; Sasmal et al., 2025).

Non-nutritive sucking via a pacifier is a simpler, widely used intervention that may enhance sucking organization through repetitive oromotor activity and provide calming effects via parasympathetic activation. However, robust comparative data between PIOMI and pacifier use are lacking, particularly from adequately powered randomized trials. A recent pilot study by Cakirli et al. (2025) highlighted this gap, noting that small sample sizes (n=13 per group) limit the generalizability of findings. The present trial addresses this gap by enrolling a larger cohort and employing rigorous methodology.

This single-center, three-arm parallel-group trial will be conducted in the NICU of a major teaching hospital in Baghdad, Iraq, reflecting the local preterm population and clinical practices. Participants will be randomly assigned to one of three groups: PIOMI (7-day protocol), pacifier use (7-day non-nutritive sucking), or routine care (standard NICU feeding support). Blinding of participants and care providers is not feasible due to the nature of the interventions; however, outcome assessors responsible for measuring feeding milestones and weight will be masked to group assignment to minimize detection bias.

The study's conceptual framework integrates physiological, developmental, and clinical perspectives to evaluate how structured oromotor stimulation influences feeding outcomes. By comparing two active interventions with routine care, the trial aims to identify the most effective strategy for facilitating oral feeding in preterm infants, thereby potentially reducing hospitalization duration and improving long-term developmental outcomes.

All procedures will be conducted in accordance with the Declaration of Helsinki and local regulatory requirements. Written informed consent will be obtained from parents or legal guardians before enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laith Abdul Hani, MSc Cand.; Phone Number: +9647801253663; Email: laith.abd2404m@conursing.uobaghdad.edu.iq
• Study Contact Backup: Name: Zaid W Ajel, PhD, Associate Professor; Phone Number: +9647727479781; Email: zaid_ahjil@conursing.uobaghdad.edu.iq

Study Locations

• Iraq
  • Thi Qar
    • Nasiriyah, Thi Qar, Iraq
      • Al-Habobi Teaching Hospital
      • Contact: Zaid W Ajel, PhD, Associate Professor; Phone Number: +9647727479781; Email: zaid_ahjil@conursing.uobaghdad.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. - Preterm infants born at 26-32 weeks of gestational age
2. - Clinically stable (no mechanical ventilation, no major congenital anomalies, no necrotizing enterocolitis)
3. - Birth weight ≥1000 grams
4. - Informed consent obtained from parents or legal guardians

Exclusion Criteria:

1. Orofacial malformations (e.g., cleft lip, cleft palate)
2. Neurological impairment affecting sucking ability (e.g., intraventricular hemorrhage grade III or IV, periventricular leukomalacia)
3. Infants who received any prior structured oral motor intervention
4. Major congenital anomalies or genetic syndromes affecting feeding or development
5. Infants requiring surgical interventions during the study period
6. Lack of parental consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Premature Infant Oral Motor Intervention (PIOMI) Group; Premature 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.	Behavioral: Premature Infant Oral Motor Intervention (PIOMI); 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.
Active Comparator: Pacifier Use Group; This 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.	Device: Pacifier Use (Non-Nutritive Sucking); 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.
No Intervention: control group; Control 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Zaid W Ajel, PhD, Assoc Prof, University of Baghdad / College of Nursing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2026
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Weight Gain; NICU; Length of Hospital Stay; Preterm Infant; Premature Infant; Oral Feeding; Neonatal Intensive Care; Non-nutritive Sucking; Sucking Behavior; Feeding Difficulties; PIOMI; Pacifier Use; Oral Motor Intervention; Feeding Transition
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Body Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Premature Birth; Weight Gain; Sucking Behavior
• Other Study ID Numbers: PIOMI-2025-001; Other Identifier (Other Identifier: Research Ethics Committee, College of Nursing, Univ. of Baghdad, Min. of Higher Educ. & Sci. Research); Approval Number:66 (Other Identifier: Research Ethics Committee, College of Nursing, Univ. of Baghdad, Min. of Higher Educ. & Sci. Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No