An observational study in Neonatal Patients Undergoing Major Non-cardiac Surgery and Congenital Anomaly, sponsored by The Hospital for Sick Children. Not yet recruiting at 3 sites in 2 countries. Open to participants aged 24 Weeks to 44 Weeks. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by The Hospital for Sick Children · 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.
This study has three main goals:
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.
781 studies on the registry are indexed under Congenital Abnormalities; 77 are open to participants now.
This study's planned enrollment of 400 is above the median of 250 across 257 observational studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Neonates receiving care in tertiary-level neonatal intensive care units (NICUs) at participating academic hospitals in Canada and the United Kingdom. Participants will be drawn from infants admitted to these NICUs who require major non-cardiac surgical intervention as part of their routine clinical care. The study population represents a broad and clinically relevant sample of neonates undergoing major surgery within high-acuity NICU settings. In addition, healthcare professionals involved in the perioperative care of neonates at participating sites will be recruited to participate in implementation-focused components of the study, including interviews and focus groups.
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Effectiveness aims:
Implementation aims:
Exclusion Criteria
Effectiveness aims:
Implementation aims:
- Healthcare providers and/or caregivers who do not consent to participate in Implementation surveys or interviews.
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.
Other: Pre-nERAS Guideline Implementation Intervention
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.
Other: Multifaceted Implementation of nERAS Guideline 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.
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.
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.
Primary surgical diagnosis
The primary surgical diagnosis of the patient will be recorded pre-operatively and post-operatively. Options include Necrotizing enterocolitis (NEC)/Intestinal perforation, Bowel obstruction, Intestinal atresia, Esophageal atresia with or without fistula (EA+/-TEF), Congenital diaphragmatic hernia (CDH), Anorectal malformation (ARM), Abdominal wall defect (gastroschisis, omphalocele), Malrotation, and/or Hydrocephalus. Investigators will also record other primary diagnoses not included in this preliminary list, if any.
Time frame: Retrospective chart review up to 7-days post-operatively.
Urgency of surgery
Investigators will retrospectively collect data on whether or not the surgery performed was urgent, emergency, or elective.
Time frame: Retrospective chart review up to 7-days post-operatively.
Invasiveness of surgery
Investigators will retrospectively collect information on whether or not the surgery was a minimally invasive surgery (MIS), an open surgery, or a converting surgery (MIS to open).
Time frame: Retrospective chart review up to 7-days post-operatively.
Comorbidities at the time of surgery
Information regarding the type and details of comorbidities will be recorded (i.e. gastrointestinal, neurological, cardiovascular, respiratory, heme, genetic, or other)
Time frame: Retrospective chart review up to 7-days post-operatively.
Surgical procedures performed
Investigators will collect information regarding the type of surgery performed. Preliminary list of surgeries include: Bowel resection + anastomosis, Stoma, Lung resection, Ommaya, Ventriculoperitoneal (VP) shunt, EA+/-TEF repair, Abdominal wall closure, Second look, Congenital diaphragmatic hernia (CDH) and/or Ladd's procedure. Procedures not included in this preliminary list will also be recorded.
Time frame: Retrospective chart review up to 7-days post-operatively.
Total surgery time
Total time taken to perform surgery will be measured by calculating the difference between surgery start time, and stop time.
Time frame: Retrospective chart review up to 7-days post-operatively.
Total anesthesia time
Total anesthesia time will be calculated via the difference between anesthesia start time and stop time.
Time frame: Retrospective chart review up to 7-days post-operatively.
Intra-operative events
Information regarding the type and details of intra-operative events will be collected (i.e. cardiovascular, respiratory, surgical/technical, anesthesia-related, metabolic, or other).
Time frame: Retrospective chart review up to 7-days post-operatively.
Antibiotic regimens
Use of antibiotics and respective regimen will be retrospectively collected.
Time frame: Retrospective chart review up to 7-days post-operatively.
Blood culture results
Information regarding blood culture test(s) and respective results (positive, negative, culture details) will be collected retrospectively.
Time frame: Retrospective chart review up to 7-days post-operatively.
Temperature regulation
Information regarding pre-operative and intra-operative temperature regulation (i.e. highest/lowest, arrival/final temperatures in the NICU, during surgery in the OR) and use of thermoregulation checklists will be collected retrospectively.
Time frame: Retrospective chart review up to 7-days post-operatively.
Pressor requirements
Investigators will record whether or not pressors were required pre-operatively and intra-operatively, such as the use of dopamine, vasopressin, epinephrine/norepinephrine, or other pressor(s).
Time frame: Retrospective chart review up to 7-days post-operatively.
Use of maintenance fluids
Use of maintenance fluids, such as total parenteral nutrition (TPN), dextrose (5%, 10%, 12.5%, 15%, \>15%), normal saline, or other types, will be recorded pre-operatively, intra-operatively and post-operatively.
Time frame: Retrospective chart review up to 7-days post-operatively.
Analgesia/Sedation medications
Information regarding pre-operative/post-operative morphine, hydromorphone, fentanyl, or other analgesia/sedation medications will be collected.
Time frame: Retrospective chart review up to 7-days post-operatively.
Regional techniques
Post-operative and intra-operative regional techniques, such as single-shot or catheter (intra-operative), or epidural/catheter based regional techniques (post-operative) will be recorded.
Time frame: Retrospective chart review up to 7-days post-operatively.
Post-operative paralysis
Information on whether the patient experienced post-operative paralysis, as well as the number of hours of the paralysis episode, will be recorded.
Time frame: Retrospective chart review up to 7-days post-operatively.
Blood Product Tranfusions
Information regarding blood products transfusions, including the hemoglobin levels, method of determining hemoglobin levels (e.g. complete blood count, blood gas), and blood source (e.g. arterial, capillary, venous), will be collected.
Time frame: Retrospective chart review up to 7-days post-operatively.
Blood Product Transfusions: Reactions
Reactions from blood transfusion products, including transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), allergy, ABO-mismatch, or others, will be recorded.
Time frame: Retrospective chart review up to 7-days post-operatively.
Perioperative communications
Information on use of a pre-operative or post-operative huddle will be collected.
Time frame: Retrospective chart review up to 7-days post-operatively.
Parental involvement
Post-operative involvement of parents will be detailed in data collection, such as instances, type (e.g. skin-to-skin, clothed, or other), and duration of parental holding, and documentation of stoma education.
Time frame: Retrospective chart review up to 7-days post-operatively.
Pre-operative fasting
Information regarding pre-operative feeding, such as type of feed (e.g. breastmilk, fortified breastmilk, formula, total parenteral nutrition (TPN), or other), and time of feeding will be recorded retrospectively.
Time frame: Retrospective chart review up to 7-days post-operatively.
Surgical site preparation
Surgical site preparation (i.e. use of Betadine, Chlorohexidine (0.5% and/or 2%), or other) will be recorded retrospectively.
Time frame: Retrospective chart review up to 7-days post-operatively.
Modes of ventilation: Pre-operative/Intra-operative ventilation
Information regarding pre-operative/intra-operative modes of ventilation will be recorded, such as: use of room air, nasal prongs/low flow, heated high flow, CPAP, BiPAP, intubation with conventional ventilation, intubation with high frequency oscillator, jet ventilation, or other type.
Time frame: Retrospective chart review up to 7-days post-operatively.
Modes of ventilation: Intubations and Extubations
Intra-operative, unplanned/planned intubations and extubations, including details on Endotracheal intubation (ETT) or Laryngeal mask airway (LMA) will be recorded retrospectively (e.g. time, size, cuffed/uncuffed ETT, which team performed intubation). Time of post-operative intubations and extubations will also be recorded.
Time frame: Retrospective chart review up to 7-days post-operatively.
Modes of ventilation: Intra-operative CO2 monitoring
Instance of CO2 monitoring, and mode of CO2 monitoring (e.g. tcCO2, end tidal CO2, or other) will be recorded retrospectively.
Time frame: Retrospective chart review up to 7-days post-operatively.
Modes of ventilation: intra-operative tidal volume
Intra-operative tidal volume will be measured and recorded in ml/kg.
Time frame: Retrospective chart review up to 7-days post-operatively.
Modes of ventilation: Intra-operative PEEP
Positive end-expiratory pressure (PEEP) will be measured and recorded under the following units: mmHg.
Time frame: Retrospective chart review up to 7-days post-operatively.
Glucose Monitoring
Instances, as well as highest and lowest levels of glucose within 24 hours will be measuring pre-operative, intra-operative and post-operatively. Investigators will use 'mmol/L' as the units.
Time frame: Retrospective chart review up to 7-days post-operatively.
Emergency Department Admissions
Instances of emergency department admissions, diagnosis, and admission location post-visit will be recorded retrospectively.
Time frame: Retrospective chart review up to 30-days or 12-months post-operatively.
Unplanned/Planned hospital re-admissions
Instances of hospital re-admissions, location that the patient was re-admitted from, diagnosis, and length of stay will be recorded retrospectively.
Time frame: Retrospective chart review up to 30-days and 12-months post-operatively.
Neurodevelopmental Outcomes: Continuous Electroencephalography (cEEG)
cEEG readings will be recorded retrospectively. Details collected from the cEEG readings upon chart review include: NMT TOF Count/Ratio, Spectral Edge Frequencies (Left, Right, 1st cEEG reading, 2nd cEEG reading), Burst Suppression Ratio (Left, Right), Post tetanic count, twitch height, NMT Double-burst stimulation (DBS) count, Absolute alpha (Left, Right), Absolute beta (Left, Right), Absolute delta (Left, Right), Absolute theta (Left, Right), % power of the alpha/beta/delta/theta bands (CH1 and CH2).
Time frame: Retrospective chart review up to 7-days post-operatively.
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Plan to share: No — Only de-identified and pooled IPD used in the results for publications will be shared.
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