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.

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

Feeding Difficulties

Sucking Behavior

Premature

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.

Premature Infant Oral Motor Intervention (PIOMI)

Pacifier Use (Non-Nutritive Sucking)

The Effect of the Premature Infant Oral Motor Intervention Versus Pacifier Use in the Transition to Oral Feeding in Preterm Infants

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)

Principal Investigator

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.

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?