Implementing Enhanced Recovery After Surgery (ERAS) for Neonates Undergoing Major Surgery: A Prospective Multicenter Stepped-Wedge Cluster Hybrid Effectiveness-Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Perioperative Management (POM) Score
研究概览
简要总结
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:
- To evaluate whether the nERAS guidelines improve short-term health outcomes for newborns who need major surgery,
- To understand how well the guidelines are adopted and followed by healthcare teams,
- 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.
详细描述
This study is being conducted at three hospitals: Alberta Children's Hospital (Calgary, Canada), The Hospital for Sick Children (Toronto, Canada), and Great Ormond Street Hospital (London, United Kingdom). The purpose of the study is to evaluate the effectiveness of recently published Neonatal Enhanced Recovery After Surgery (ERAS) guidelines and to understand how best to implement these guidelines in Neonatal Intensive Care Units (NICUs).
The Neonatal ERAS guidelines are evidence-based recommendations designed to improve the care of newborn infants who require major non-cardiac surgery. The study will compare outcomes before and after the implementation of these guidelines. Because the guidelines reflect best practices in neonatal surgical care, no additional study-specific treatments, procedures, or tests will be required for participating patients.
Each participating NICU will serve as its own comparison group. During an initial 6-month observation period, patient outcomes will be measured while usual care is provided. This will be followed by a 12-month active implementation period, during which healthcare teams will receive additional support and resources to implement the Neonatal ERAS guidelines. All three hospitals will participate in both phases of the study, with implementation occurring sequentially across sites.
The study will collect information on perioperative stability using the Perioperative Management (POM) Score, which includes measures such as body temperature, blood pH, carbon dioxide levels (pCO2), blood glucose levels, and unintended respiratory events. The study will also collect information on clinical outcomes during the first 30 days after surgery.
The study design ensures that all participating NICUs receive the Neonatal ERAS implementation strategy. Introducing the guidelines in stages allows each hospital to adapt the program to its local environment while enabling researchers to compare outcomes both within and between sites over time. The participating hospitals were selected to represent different types of neonatal surgical centres, including both Canadian and international sites, to improve the relevance and generalizability of the findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Weeks 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Pre-Implementation Cohort: Standard Care
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.
干预措施: Pre-nERAS Guideline Implementation Intervention (Other)
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/across 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/prolonged intubations). For internal-external facilitation, a research coordinator/assistant 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.
干预措施: Multifaceted Implementation of nERAS Guideline Intervention (Other)
结局指标
主要结局
Perioperative Management (POM) Score
时间窗: The POM Score is derived from: blood tests within one hour after surgery, body temperature (measured within one hour of return to NICU from surgery), and unintended respiratory events within the first 24 hours post-operatively
The investigators will use the Perioperative Management Score (temperature, pH, pCO2, glucose, and unintended respiratory events) to measure clinical effectiveness of nERAS and reflect perioperative stability and recovery pre-implementation and during active- implementation of nERAS. The POM Score was developed by the Children's Hospital Neonatal Consortium using relevant literature and expert review. It provides a pragmatic objective measure of neonatal physiologic status after surgery using investigations that are completed as part of routine clinical care. This measure also directly reflects at least 50% of the recommendations in nERAS (temperature regulation, perioperative ventilation, fluid management, perioperative glucose control, transfusion thresholds, and team communication).
Adoption of nERAS
时间窗: Outcome will be measured within 30-days of surgery, prior to structured implementation, during active implementation, and during sustainability audits at 6 and 12-months after active-implementation of nERAS has been completed.
Through retrospective chart review and using standardized definitions (i.e. primary and secondary outcomes from the effectiveness arm of the NEO Study), this outcome will assess concordance between care provided and evidence-based guideline recommended care.
次要结局
- Neurodevelopmental Outcomes: Bayley Scales of Infant and Toddler Development, 4th Edition (BSID-IV)(18-months corrected age)
- Number of Participants with Surgical Site Infections (SSIs)(This outcome will be measured via retrospective chart review using standardized definitions within 30-days of surgery.)
- Number of Participants with Sepsis(Retrospective chart review using standardized definitions within 30-days of surgery)
- Number of Participants with Unplanned reoperation(Retrospective chart review using standardized definitions within 30-days of surgery, and 1-year of surgery.)
- Number of Participants with Opioid Use(Retrospective chart review of cumulative dose, days on narcotics, narcotic prescription on discharge, cumulative dose of narcotics within first 7 days after surgery, and number of days of post-operative narcotic-use (30-days post-operatively).)
- Number of Patient Mortalities(Retrospective chart review within 30-days and 1-year of surgery.)
- Index NICU Length of Stay(Retrospective chart review documenting readiness for discharge to ward (regardless of bed availability) up to 1-year after surgery.)
- Total Hospital Length of Stay(Retrospective chart review up to 1-year post-operatively.)
- Number of Patient Readmissions(Retrospective chart review at hospital of index presentation within 30-days of discharge.)
- Neurodevelopmental Outcomes: Hammersmith Infant Neurological Examination (HINE) Score(4-months corrected gestational age (cGA) for HINE)
- Neurodevelopmental Outcomes: Alberta Fine Motor Scale (AIMS)(4 + 8 + 12-months cGA for AIMS)
- Neurodevelopmental Outcomes: Posture and Fine Motor Assessment (PFMA)(8 + 12months cGA for PFMA)
- Implementation Readiness: Atlas Context Assessments(Pre-implementation and Progress Surveys will be delivered within the first 6-months of the study, and Pulse Check Surveys will be delivered within 12-months of the study.)
- Acceptability of Intervention (AIM): Healthcare Providers(Surveys will be administered during Pre-implementation (0-6 months of the study) and active implementation phases of nERAS guidelines (6-12 months of the study))
- Appropriateness of Intervention (IAM): Healthcare Providers(Surveys will be administered during Pre-implementation (0-6 months of the study) and active implementation phases of nERAS guidelines (6-12 months of the study))
- Feasibility of Intervention (FIM): Healthcare Providers(Surveys will be administered during Pre-implementation (0-6 months of the study) and active implementation phases of nERAS guidelines (6-12 months of the study))
- Acceptability of Intervention (AIM): Family Caregivers(Performed during active implementation (6-12 months of the study) of nERAS guidelines)
- Appropriateness of Intervention (IAM): Family Caregivers(Performed during active implementation (6-12 months of the study) of nERAS guidelines)
- Number of Patients with Unplanned Re-intubation (Additional Exploratory Outcome)(Retrospective chart review using standardized definitions up to 30-days post-operatively)
- Number of Central Line Days (Additional Exploratory Outcome)(Retrospective chart using standardized definitions up to 30-days post-operatively)
- Number of Days to Full Enteral Feeds (Additional Exploratory Outcome)(Retrospective chart using standardized definitions up to 1-year post-operatively)
- Number of Days of Supplemental Respiratory Support (Additional Exploratory Outcome)(Retrospective chart using standardized definitions up to 1-year post-operatively)
- Number of Patients with Necrotizing Enterocolitis (Additional Exploratory Outcome)(Retrospective chart using standardized definitions up to 30-days post-operatively)
- Number of Patients receiving Breastmilk at Discharge (Additional Exploratory Outcome)(Retrospective chart using standardized definitions up to 30-days post-operatively)
- Growth Parameters: Head circumference (Additional Exploratory Outcome)(Retrospective chart using standardized definitions up to 30-days post-operatively)
- Growth Parameters: Length (Additional Exploratory Outcome)(Retrospective chart using standardized definitions up to 30-days post-operatively, and measured at birth.)
- Growth Parameters: Weight (Additional Exploratory Outcome)(Retrospective chart using standardized definitions up to 30-days post-operatively, and measured at birth.)
- Number of Patients with Tube Feeding at Discharge(Retrospective chart using standardized definitions at discharge and up to 1-year post-operatively)
- Number of Patients with Total Parenteral Nutrition (TPN)(Retrospective chart using standardized definitions at discharge and up to 1-year post-operatively)
- Confirmed diagnoses of Brain injuries detected via Head Ultrasound(Retrospective chart using standardized definitions pre/post-operatively, but recorded at 18-month follow-up.)
- Confirmed diagnoses of Brain injuries detected via Head MRI(Retrospective chart using standardized definitions at term/18-month follow-up.)
研究者
Mercedes Pilkington
Pediatric Surgeon, Division of General and Thoracic Surgery, Principal Investigator, Assistant Professor
The Hospital for Sick Children