[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546466":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":40,"locations":50,"responsibleParty":71,"collaborators":73,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":45,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":52,"whyStopped":45,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Fundació Sant Joan de Déu","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group PIOMI","EXPERIMENTAL","Participants will receive:\n\n1. The traditional intervention Newborn Individualized Development Care and Assessment Program (NIDCAP) model of the Neonatal Intensive Care Unit (NICU) .The nurse providing direct care to the patient and family, will carry out the relevant care of the patient.\n2. The Premature Oral Motor Intervention (PIOMI) .The family will apply the PIOMI , 7 activities are intraoral stimulation for 10 consecutive days, twice a day, 5 minutes.\n3. Gustatory stimulation technique:the application of oropharyngeal colostrum, a 0.5 milliliter twice a day\n4. Olfactory stimulation Technique:A swab is moistened in breast milk and placed near the nose for one minute, twice a day.",[13],"Other: Experimental group PIOMI",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group NIDCAP","SHAM_COMPARATOR","Participants will receive :\n\n1.The traditional intervention Newborn Individualized Development Care and Assessment Program (NIDCAP) model of the Neonatal Intensive Care Unit (NICU).The nurse providing direct care to the patient and family, will carry out the relevant care of the patient.\n\n3.Gustatory stimulation technique:the application of oropharyngeal colostrum, a 0.5 milliliter twice a day\n\n4.Olfactory stimulation Technique:A swab is moistened in breast milk and placed near the nose for one minute, twice a day.",[19],"Other: Control group NIDCAP",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Experimental group PIOMI","A group treated with the application of the care model Newborn Individualized Development Care and Assessment Program (NIDCAP) in the Neonatal Intensive Unit Care (NICU)+PIOMI",[9],[26],"PIOMI+NIDCAP",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Control group NIDCAP","A group treated with the application of the care model Newborn Individualized Development Care and Assessment Program (NIDCAP) in the Neonatal Intensive Unit Care (NICU)",[15],[32],"NIDCAP",[34,38],{"name":35,"affiliation":36,"role":37},"Raquel García Ezquerra","Sant Joan de Déu Hospital","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":36,"role":37},"Vanesa Ejarque Marin",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Raquel García Equerra","CONTACT","639423251",null,"raquel.garciae@sjd.es",{"name":39,"role":43,"phone":48,"phoneExt":45,"email":49},"637797057","vanesa.ejarque@sjd.es",[51],{"facility":35,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Barcelona","Catalonia","08096","Spain","ES",{"type":59,"coordinates":60},"Point",[61,62],2.15899,41.38879,{"lat":62,"lon":61},[65,66,68,69],{"name":35,"role":43,"phone":45,"phoneExt":45,"email":46},{"name":39,"role":43,"phone":45,"phoneExt":45,"email":67},"vanesaem35.vem@gmail.com",{"name":35,"role":37,"phone":45,"phoneExt":45,"email":45},{"name":39,"role":70,"phone":45,"phoneExt":45,"email":45},"SUB_INVESTIGATOR",{"type":72,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[74,76,79,81,83],{"name":75,"class":6},"Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica",{"name":77,"class":78},"Nexe Foundation","UNKNOWN",{"name":80,"class":6},"University Ramon Llull",{"name":82,"class":78},"Borja Institute of Bioethics",{"name":84,"class":78},"Institut de Recerca Sant Joan de Déu","100546466","effects-of-the-application-of-piomi-in-the-oral-feeding-of-premature-100546466",false,"NCT06395298","Effects of the Application of PIOMI in the Oral Feeding of Premature","Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial","PIOMI","Inclusion Criteria:\n\n* Neonates born at the Sant Joan de Déu Hospital with a gestational age between 29-30 weeks carrying an external feeding device due to the difficulty of oral feeding and that the medical team in charge considers clinically stable.\n\nExclusion Criteria:\n\n* Endotracheal intubation or high-flow ventilatory support.\n* Exclusive parenteral nutrition.\n* Hyporeactive due to the use of sedative drugs.\n* Condition of prematurity associated with other pathologies (syndromes, acquired brain damage, gastrointestinal malformations, airway and craniofacial malformations).","ALL","29 Weeks","30 Weeks",{"count":97,"type":98},35,"ESTIMATED","INTERVENTIONAL",[101],"NA","The goal of this clinical trial is assess whether the application of the premature oral motor intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), allows withdrawal of the external feeding device with guarantees of the patient's nutritional status, determining breastfeeding rates at hospital discharge and swallowing safety earlier than if only the care activity corresponding to the NIDCAP model is carried out, as well as the applicability of this standardised protocol in the neonatal intensive care unit of a tertiary hospital.",[104,105,106],"Dysphagia","Disorder; Feeding, Newborn","Premature",[108,109,110,111,112,113,114],"Swallowing","Swallowing disorders","Nutritional support","Feeding disorders","Preterm","Neonates","Sucking Behavior","2024-04-29",{"date":117,"type":118},"2024-05-02","ACTUAL",{"date":120,"type":118},"2023-02-13",{"date":122,"type":98},"2026-12-30",{"name":5,"class":6},1]