[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628319":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":66,"collaborators":24,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":103,"whyStopped":24,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Baghdad","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Premature Infant Oral Motor Intervention (PIOMI) Group","EXPERIMENTAL","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.",[13],"Behavioral: Premature Infant Oral Motor Intervention (PIOMI)",{"label":15,"type":16,"description":17,"interventionNames":18},"Pacifier Use Group","ACTIVE_COMPARATOR","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.",[19],"Device: Pacifier Use (Non-Nutritive Sucking)",{"label":21,"type":22,"description":23,"interventionNames":24},"control group","NO_INTERVENTION","Control Group (No Intervention)\n\nThis 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.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"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.",[9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":24},"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.",[15],[37],{"name":38,"affiliation":39,"role":40},"Zaid W Ajel, PhD, Assoc Prof","University of Baghdad \u002F College of Nursing","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":24,"email":46},"Laith Abdul Hani, MSc Cand.","CONTACT","+9647801253663","laith.abd2404m@conursing.uobaghdad.edu.iq",{"name":48,"role":44,"phone":49,"phoneExt":24,"email":50},"Zaid W Ajel, PhD, Associate Professor","+9647727479781","zaid_ahjil@conursing.uobaghdad.edu.iq",[52],{"facility":53,"status":24,"city":54,"state":55,"zip":24,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Al-Habobi Teaching Hospital","Nasiriyah","Thi Qar","Iraq","IQ",{"type":59,"coordinates":60},"Point",[61,62],46.25726,31.05799,{"lat":62,"lon":61},[65],{"name":48,"role":44,"phone":49,"phoneExt":24,"email":50},{"type":40,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Laith Abd AL-Karim Hani","Principal Investigator","100628319","premature-infant-oral-motor-intervention-vs-pacifier-for-oral-feeding-transition-in-preterm-infants-100628319",false,"NCT07460089","Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants","The Effect of the Premature Infant Oral Motor Intervention Versus Pacifier Use in the Transition to Oral Feeding in Preterm Infants","PIOMI","Inclusion Criteria:\n\n1. \\- Preterm infants born at 26-32 weeks of gestational age\n2. \\- Clinically stable (no mechanical ventilation, no major congenital anomalies, no necrotizing enterocolitis)\n3. \\- Birth weight ≥1000 grams\n4. \\- Informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n1. Orofacial malformations (e.g., cleft lip, cleft palate)\n2. Neurological impairment affecting sucking ability (e.g., intraventricular hemorrhage grade III or IV, periventricular leukomalacia)\n3. Infants who received any prior structured oral motor intervention\n4. Major congenital anomalies or genetic syndromes affecting feeding or development\n5. Infants requiring surgical interventions during the study period\n6. Lack of parental consent","ALL","1 Day","28 Days",{"count":81,"type":82},150,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.",[88,89,90],"Feeding Difficulties","Sucking Behavior","Premature",[92,93,94,88,89,75,95,96,97,98,99,100,101,102],"Premature Infant","Preterm Infant","Oral Feeding","Pacifier Use","Non-nutritive Sucking","Oral Motor Intervention","Neonatal Intensive Care","NICU","Feeding Transition","Weight Gain","Length of Hospital Stay","NOT_YET_RECRUITING","2026-03-06",{"date":106,"type":107},"2026-03-10","ACTUAL",{"date":106,"type":82},{"date":110,"type":82},"2026-05-30",{"name":5,"class":6},1]