[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652289":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":44,"responsibleParty":96,"collaborators":99,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":10,"studyType":117,"phases":10,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":133,"whyStopped":10,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-Implementation Cohort: Standard Care",null,"No study related interventions will be introduced here. The cohort will represent a group of patients and healthcare providers prior to active implementation of nERAS guidelines.",[13],"Other: Pre-nERAS Guideline Implementation Intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Active Implementation Cohort","A multifaceted implementation strategy will be employed to include three components: Audit and feedback; Adapt and tailor; and Internal-external facilitation. The implementation strategy will be shaped by the site-specific Implementation Readiness Assessments. Audit and feedback will provide each cluster with their monthly clinical and adoption outcomes (e.g., 3 SSI, 100% adherence with preoperative antibiotics within one hour of incision). Adapt and tailor will identify areas of need within\u002Facross clusters and mini-PDSA cycles for selected outcomes will be supported (e.g., development of 'extubation in the OR' guideline if a cluster identifies unnecessary\u002Fprolonged intubations). For internal-external facilitation, a research coordinator\u002Fassistant will provide implementation support at each cluster, with existing QI and clinical teams. Once a site transitions to Active-Implementation, they will be linked to other site's facilitators for sharing of experience and resources.",[18],"Other: Multifaceted Implementation of nERAS Guideline Intervention",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Pre-nERAS Guideline Implementation Intervention","Neonates receiving standard perioperative care prior to implementation of the nERAS guideline at their site. Care will be delivered according to existing local clinical practices and protocols.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Multifaceted Implementation of nERAS Guideline Intervention","The intervention of interest is exposure to the nERAS care pathway, a bundled, evidence-informed set of perioperative care recommendations designed to standardize and optimize perioperative management for neonates undergoing major non-cardiac surgery. The nERAS pathway includes recommendations across the preoperative, intraoperative, and postoperative phases of care, including but not limited to nutritional optimization, fluid management, analgesia, temperature regulation, respiratory support, and early mobilization and feeding. Participants will not be randomized to treatment arms. Instead, exposure to the intervention will occur at the cluster level using a stepped-wedge design, whereby participating NICUs (Alberta's Children's Hospital (ACH), The Hospital for Sick Children (SickKids), and Great Ormond Street Hospital (GOSH)) sequentially transition from usual care to implementation of the nERAS pathway.",[15],[29],{"name":30,"affiliation":5,"role":31},"Mercedes Pilkington, MD, MGSC, FRCSC","PRINCIPAL_INVESTIGATOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Tabina A Ahmed, BSc., MSc.","CONTACT","416-813-7654","302196","tabina.ahmed@sickkids.ca",{"name":40,"role":35,"phone":41,"phoneExt":42,"email":43},"Eveline Lapidus-Krol, BSc., MSc.","416-813-6542","306542","eveline.lapidus-krol@sickkids.ca",[45,65,78],{"facility":46,"status":10,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Alberta Children's Hospital","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":53,"coordinates":54},"Point",[55,56],-114.08529,51.05011,{"lat":56,"lon":55},[59,63],{"name":60,"role":35,"phone":61,"phoneExt":10,"email":62},"Karolina Kogut, BA., MPH.","(403) 955-7211","kkogut@ucalgary.ca",{"name":64,"role":31,"phone":10,"phoneExt":10,"email":10},"Mary Brindle, MD, MPH",{"facility":5,"status":10,"city":66,"state":67,"zip":68,"country":50,"countryCode":51,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Toronto","Ontario","M5G 1X8",{"type":53,"coordinates":70},[71,72],-79.39864,43.70643,{"lat":72,"lon":71},[75,76,77],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},{"name":40,"role":35,"phone":41,"phoneExt":42,"email":43},{"name":30,"role":31,"phone":10,"phoneExt":10,"email":10},{"facility":79,"status":10,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Great Ormond Street Hospital","London","Greater London","WC1N 3BH","United Kingdom","UK",{"type":53,"coordinates":86},[87,88],-0.12574,51.50853,{"lat":88,"lon":87},[91,95],{"name":92,"role":35,"phone":93,"phoneExt":10,"email":94},"David de Beer, MB ChB, FRCA","+44 (0)20 3965 9900","David.DeBeer@gosh.nhs.uk",{"name":92,"role":31,"phone":10,"phoneExt":10,"email":10},{"type":31,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Mercedes Pilkington","Pediatric Surgeon, Division of General and Thoracic Surgery, Principal Investigator, Assistant Professor",[100,101],{"name":46,"class":6},{"name":102,"class":6},"Great Ormond Street Hospital for Children NHS Foundation Trust","100652289","neonatal-enhanced-recovery-after-surgery-eras-outcomes-study-100652289",false,"NCT07771478","Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study","Implementing Enhanced Recovery After Surgery (ERAS) for Neonates Undergoing Major Surgery: A Prospective Multicenter Stepped-Wedge Cluster Hybrid Effectiveness-Implementation Study","NEO","Inclusion Criteria\n\nEffectiveness aims:\n\n* Consent provided by parent\u002Flegal guardian\n* Infant aged ≥24 weeks gestational age at birth and \\\u003CcGA 44 weeks at time of index surgery\n* Requires major non-cardiac surgery requiring general anesthetic (e.g., thoracotomy, laparotomy, ventriculoperitoneal shunt, choanal atresia repair, etc.)\n* Admitted preoperatively to a study NICU (HSC, ACH, or GOSH)\n\nImplementation aims:\n\n* Healthcare providers (surgeons, anesthesiologists, neonatologists, and nurses) who provide direct care for eligible infants described above\n* Caregivers of eligible infants described above (caregiver role to be defined by family and may include parent(s) and\u002For extended family members)\n\nExclusion Criteria\n\nEffectiveness aims:\n\n* Infants undergoing cardiac surgery as sole index surgical intervention, sole minor index surgery (e.g., central line placement, eye exam under anesthesia)\n* Born at less than 24 weeks estimated gestational age or greater than 44 weeks corrected gestation age on day of index surgery\n* Intraoperative mortality\n* Genetic anomaly associated with lethality (e.g., trisomy 13 or 18)\n* Preoperative ECMO (extra-corporeal membrane oxygenation) cannulation\n* Fetal intervention (e.g, FETO for CDH)\n\nImplementation aims:\n\n\\- Healthcare providers and\u002For caregivers who do not consent to participate in Implementation surveys or interviews.","ALL","24 Weeks","44 Weeks",{"count":115,"type":116},400,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to improve the way newborn babies are cared for before, during, and after major surgery. Surgery can be very stressful on a baby's body. This study looks at whether a structured care plan called Neonatal Enhanced Recovery After Surgery (nERAS) can help reduce complications and improve recovery.\n\nThis study has three main goals:\n\n1. To evaluate whether the nERAS guidelines improve short-term health outcomes for newborns who need major surgery,\n2. To understand how well the guidelines are adopted and followed by healthcare teams,\n3. To study longer-term development outcomes (up to 18 months after surgery) for a group of babies treated under this care pathway.\n\nResearchers will compare babies who received standard surgical care before nERAS was introduced with babies who received care after nERAS was implemented with a multifaceted implementation strategy. This will help determine whether the guidelines improve recovery and overall outcomes.\n\nThe study involves reviewing medical records of newborns who had surgery. In addition, healthcare providers and parents or caregivers may be asked to complete surveys or participate in interviews or focus groups to share their experiences with this care approach.",[120,121],"Neonatal Patients Undergoing Major Non-cardiac Surgery","Congenital Anomaly",[123,124,125,126,127,128,129,130,131,132],"Enhanced Recovery After Surgery","Neonatal surgery","Perioperative care","NICU","Guideline implementation","Guideline effectiveness","Neurodevelopmental outcomes","Neonatal ERAS","ERAS","Surgery","NOT_YET_RECRUITING","2026-08-14",{"date":136,"type":137},"2026-08-18","ACTUAL",{"date":139,"type":116},"2026-08-03",{"date":141,"type":116},"2029-12-15",{"name":5,"class":6},3]