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Sponsor: The Hospital for Sick Children
Conditions: Neonatal Patients Undergoing Major Non-cardiac Surgery, Congenital Anomaly
Interventions: Pre-nERAS Guideline Implementation Intervention, Multifaceted Implementation of nERAS Guideline Intervention
Countries: Canada, United Kingdom
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. This study has three main goals: 1. To evaluate whether the nERAS guidelines improve short-term health outcomes for newborns who need major surgery, 2. To understand how well the guidelines are adopted and followed by healthcare teams, 3. To study longer-term development outcomes (up to 18 months after surgery) for a group of babies treated under this care pathway. Researchers 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. The 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.
Sex: ALL
Age: 24 Weeks to 44 Weeks
Healthy volunteers: No
Study type: OBSERVATIONAL
Inclusion Criteria Effectiveness aims: * Consent provided by parent/legal guardian * Infant aged ≥24 weeks gestational age at birth and \<cGA 44 weeks at time of index surgery * Requires major non-cardiac surgery requiring general anesthetic (e.g., thoracotomy, laparotomy, ventriculoperitoneal shunt, choanal atresia repair, etc.) * Admitted preoperatively to a study NICU (HSC, ACH, or GOSH) Implementation aims: * Healthcare providers (surgeons, anesthesiologists, neonatologists, and nurses) who provide direct care for eligible infants described above * Caregivers of eligible infants described above (caregiver role to be defined by family and may include parent(s) and/or extended family members) Exclusion Criteria Effectiveness aims: * Infants undergoing cardiac surgery as sole index surgical intervention, sole minor index surgery (e.g., central line placement, eye exam under anesthesia) * Born at less than 24 weeks estimated gestational age or greater than 44 weeks corrected gestation age on day of index surgery * Intraoperative mortality * Genetic anomaly associated with lethality (e.g., trisomy 13 or 18) * Preoperative ECMO (extra-corporeal membrane oxygenation) cannulation * Fetal intervention (e.g, FETO for CDH) Implementation aims: \- Healthcare providers and/or caregivers who do not consent to participate in Implementation surveys or interviews.
- Calgary, Alberta, Canada
- Toronto, Ontario, Canada
- London, Greater London, United Kingdom