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.
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. Eligible participants will be newborn infants admitted to the NICU at one of the participating hospitals who require major non-cardiac surgery and return to the NICU for at least one night after surgery. Infants must be between 24 and 44 weeks corrected gestational age at the time of surgery. Each study site will include a 6-month pre-implementation cohort and a 12-month active implementation cohort. Infants enrolled at Alberta Children's Hospital and Great Ormond Street Hospital will be followed for up to 12 months after surgery. Infants enrolled at The Hospital for Sick Children will be followed for up to 18 months because additional neurodevelopmental follow-up will be performed at that site. Due to the staggered implementation across hospitals, the study is expected to take approximately 4.5 years to complete. All patient outcome data will be collected through retrospective review of medical records. No study-specific patient assessments, tests, or procedures are required because all information collected is part of routine clinical care. Because each hospital will transition from usual care to active implementation at a known time, it will not be possible to blind study staff collecting the data. The implementation component of the study will be evaluated through retrospective chart reviews to measure adoption of the guidelines, as well as surveys, interviews, and focus group discussions with healthcare providers and family caregivers to understand barriers and facilitators to implementation.
Study Type
OBSERVATIONAL
Enrollment
400
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.
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.
Alberta Children's Hospital
Calgary, Alberta, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Great Ormond Street Hospital
London, Greater London, United Kingdom
Perioperative Management (POM) Score
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).
Time frame: 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
Adoption of nERAS
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.
Time frame: 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.
Neurodevelopmental Outcomes: Bayley Scales of Infant and Toddler Development, 4th Edition (BSID-IV)
A nested single-center cohort of prospectively enrolled infants undergoing major noncardiac surgery will examine whether nERAS implementation are measured (feasibility) and whether there is an impact on NDI at 18-month corrected age. All infants at HSC who undergo standardized neurodevelopmental follow-up as part of routine care after hospital discharge will be included. The primary outcome of NDI is defined as any grade cerebral palsy or composite motor scores below 2 standard deviations as measured by the Bayley Scales of Infant and Toddler Development, 4th Edition (BSID-IV) at 18 months corrected age. BSID-IV is a comprehensive, standardized neurodevelopmental assessment tool with high reliability for evaluating developmental delays in infants and toddlers.
Time frame: 18-months corrected age
Number of Participants with Surgical Site Infections (SSIs)
Core surgical complication measuring the number of patients with surgical site infections (SSIs).
Time frame: This outcome will be measured via retrospective chart review using standardized definitions within 30-days of surgery.
Number of Participants with Sepsis
Core neonatal clinical outcome measuring the number of participants with sepsis, alongside details of blood cultures ordered.
Time frame: Retrospective chart review using standardized definitions within 30-days of surgery
Number of Participants with Unplanned reoperation
Core surgical complication measuring the number of participants with unplanned reoperation, alongside details on whether the procedure performed was a surgery or a drain.
Time frame: Retrospective chart review using standardized definitions within 30-days of surgery, and 1-year of surgery.
Number of Participants with Opioid Use
Core surgical outcome measuring the number of patients with use of opioids during, and after surgery for pain management, length of time opioid was administered, and details on the opioids prescribed.
Time frame: 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
Core neonatal clinical outcome measuring the number of mortalities in the study cohort at 30-day follow-up, and 1-year follow-up.
Time frame: Retrospective chart review within 30-days and 1-year of surgery.
Index NICU Length of Stay
Number of days spent in the NICU (total and post-operatively).
Time frame: Retrospective chart review documenting readiness for discharge to ward (regardless of bed availability) up to 1-year after surgery.
Total Hospital Length of Stay
Number of days spent in hospital (total and post-operatively)
Time frame: Retrospective chart review up to 1-year post-operatively.
Number of Patient Readmissions
Number of patients being re-admitted after index hospitalization/discharge.
Time frame: Retrospective chart review at hospital of index presentation within 30-days of discharge.
Neurodevelopmental Outcomes: Hammersmith Infant Neurological Examination (HINE) Score
The Hammersmith Infant Neurological Examination (HINE) is an objective, standardized neurological examination tool with a high predictive value for the early detection of motor delay and cerebral palsy, which will be included to detect early motor impairments and infants at an increased likelihood of cerebral palsy.
Time frame: 4-months corrected gestational age (cGA) for HINE
Neurodevelopmental Outcomes: Alberta Fine Motor Scale (AIMS)
As a part of the secondary outcomes, gross and fine motor skills will also be assessed at 4, 8 and 12 months of corrected age using the Alberta Infant Motor Scale (AIMS). a standardized observational tool used to evaluate gross motor development in infants. It focuses on weight-bearing, posture, and antigravity movements across four standard positions; supine, prone, standing, sitting.
Time frame: 4 + 8 + 12-months cGA for AIMS
Neurodevelopmental Outcomes: Posture and Fine Motor Assessment (PFMA)
The Posture and Fine Motor Assessment (PFMA) is an early intervention assessment tool in a clinical or medical setting to determine if a 2- to 12-month-old child's motor skills are developmentally delayed. The assessment is based on the dynamical systems theory and on the therapist's non-intrusive observation of the child's posture and fine motor abilities.
Time frame: 8 + 12months cGA for PFMA
Implementation Readiness: Atlas Context Assessments
Atlas Context Assessment surveys will be utilized to assess baseline readiness for nERAS implementation, to enhance generalizability of results. This tool helps healthcare facilities assess their strengths and challenges, to help with successful implementation and sustainment of improvement projects. The Atlas toolkit includes a series of anonymous surveys (i.e. pre-implementation surveys, progress surveys, and pulse check surveys) completed by leaders, healthcare providers and administrative staff, and implementation team members at various points throughout a quality-improvement project.
Time frame: 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
The Acceptability of Intervention Measure (AIM) is considered one of 'leading indicators' of implementation success. This measure can be administered to determine whether an implementation strategy is acceptable; it will be investigated independently and together among healthcare providers via surveys.
Time frame: 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
Intervention Appropriateness Measure (IAM) is considered one of the 'leading indicators' of implementation success. This measure can be administered to determine whether an implementation strategy is appropriate; it will be investigated independently and together among healthcare providers via surveys.
Time frame: 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
Feasibility of Intervention Measure (FIM) is considered one of the 'leading indicators' of implementation success. This measure can be administered to determine whether an implementation strategy is feasible; it will be investigated independently and together among healthcare providers via surveys.
Time frame: 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
Family caregivers are an integral part of the healthcare team. Their perspective will shape implementation to ensure family-centered care is enhanced at each step; surveys and semi-structured interviews assessing the Acceptability of Intervention Measure (AIM) will be performed. This measure will be investigated independently and together among family caregivers.
Time frame: Performed during active implementation (6-12 months of the study) of nERAS guidelines
Appropriateness of Intervention (IAM): Family Caregivers
Family caregivers are an integral part of the healthcare team. Their perspective will shape implementation to ensure family-centered care is enhanced at each step; surveys and semi-structured interviews assessing the Intervention Appropriateness Measure (IAM) will be performed. This measure will be investigated independently and together among family caregivers.
Time frame: Performed during active implementation (6-12 months of the study) of nERAS guidelines
Number of Patients with Unplanned Re-intubation (Additional Exploratory Outcome)
Number of patients that had been re-intubated post-operatively.
Time frame: Retrospective chart review using standardized definitions up to 30-days post-operatively
Number of Central Line Days (Additional Exploratory Outcome)
Total number of days that patients have a central venous catheter in place.
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively
Number of Days to Full Enteral Feeds (Additional Exploratory Outcome)
Number of days on full enteral feeds, intra-operatively and up to 1-year post-operatively.
Time frame: Retrospective chart using standardized definitions up to 1-year post-operatively
Number of Days of Supplemental Respiratory Support (Additional Exploratory Outcome)
Number of patients on supplemental respiratory support
Time frame: Retrospective chart using standardized definitions up to 1-year post-operatively
Number of Patients with Necrotizing Enterocolitis (Additional Exploratory Outcome)
Total number of patients with a diagnosis of necrotizing enterocolitis.
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively
Number of Patients receiving Breastmilk at Discharge (Additional Exploratory Outcome)
Core neonatal clinical outcome measuring the number of patients receiving breastmilk post-operatively/at discharge.
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively
Growth Parameters: Head circumference (Additional Exploratory Outcome)
Head circumference will be measured as percentile and z-scores, in centimeters (cm).
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively
Growth Parameters: Length (Additional Exploratory Outcome)
Length will be measured as percentile and z-scores, in centimeters (cm).
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively, and measured at birth.
Growth Parameters: Weight (Additional Exploratory Outcome)
Weight will be measured as percentile and z-scores, in centimeters (cm).
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively, and measured at birth.
Number of Patients with Tube Feeding at Discharge
Number of patients receiving tube feeding post-operatively/at discharge
Time frame: Retrospective chart using standardized definitions at discharge and up to 1-year post-operatively
Number of Patients with Total Parenteral Nutrition (TPN)
Number of patients receiving TPN intra-operatively/1-year post-surgery
Time frame: Retrospective chart using standardized definitions at discharge and up to 1-year post-operatively
Confirmed diagnoses of Brain injuries detected via Head Ultrasound
Core neonatal clinical outcome representing confirmed diagnoses of brain injuries detected via Head Ultrasound pre/post-operatively.
Time frame: Retrospective chart using standardized definitions pre/post-operatively, but recorded at 18-month follow-up.
Confirmed diagnoses of Brain injuries detected via Head MRI
Core neonatal clinical outcome representing confirmed diagnoses of brain injuries via Head MRI.
Time frame: Retrospective chart using standardized definitions at term/18-month follow-up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.