An interventional study of Premature Infant Oral Motor Intervention (PIOMI) and Pacifier Use (Non-Nutritive Sucking) in Feeding Difficulties, Sucking Behavior and Premature, sponsored by University of Baghdad. Not yet recruiting at 1 site in Iraq. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by University of Baghdad · Not applicable, Interventional, and Other
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 150 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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.
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)
Plan to share: No — 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.
Start is estimated for Mar 2026; primary completion for Apr 2026, 1 month later.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 1 month is below that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.