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.

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.

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

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.

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.