Feeding Difficulties, Premature, Sucking Behavior
Conditions
Keywords
Premature Infant, Preterm Infant, Oral Feeding, Feeding Difficulties, Sucking Behavior, PIOMI, Pacifier Use, Non-nutritive Sucking, Oral Motor Intervention, Neonatal Intensive Care, NICU, Feeding Transition, Weight Gain, Length of Hospital Stay
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.
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.
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.
DEVICEPacifier 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.
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
This study employs a parallel assignment design with three arms: 1. PIOMI Group - receives structured oral motor stimulation for 7-10 days. 2. Pacifier Group - receives non-nutritive sucking via pacifier for 7-10 days. 3. Control Group - receives routine NICU care only. A total of 150 preterm infants (gestational age 26-32 weeks) will be randomly assigned in a 1:1:1 ratio using a simple lottery method. Allocation is concealed by sequentially numbered, opaque, sealed envelopes. Participants are enrolled at a single center (teaching hospital NICU in Baghdad, Iraq) and remain in their assigned group throughout the study. Interventions are initiated once the infant is clinically stable. The primary outcome is time to achieve full oral feeding (≥120 mL/kg/day for 24 h). Secondary outcomes include hospital stay, weight gain, feeding efficiency, and early feeding skills. Outcome assessors are blinded to group assignment to minimize detection bias.
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve Full Oral Feeding | From start of intervention until achievement of full oral feeding (up to hospital discharge, approximately 8 weeks) | 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) |
Countries
Iraq
Contacts
CONTACTLaith Abdul Hani, MSc Cand.
CONTACTZaid W Ajel, PhD, Associate Professor
PRINCIPAL_INVESTIGATORZaid W Ajel, PhD, Assoc Prof
University of Baghdad / College of Nursing
Outcome results
None listed