Neonatal Patients Undergoing Major Non-cardiac SurgeryNEONCT07771478
Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study
An observational study of Neonatal Patients Undergoing Major Non-cardiac Surgery and Congenital Anomaly, run by The Hospital for Sick Children at 3 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 24 to 44 weeks
- Conditions the study is for
- Neonatal Patients Undergoing Major Non-cardiac Surgery, Congenital Anomaly
- What is being tested?
- Pre-nERAS Guideline Implementation Intervention and Multifaceted Implementation of nERAS Guideline Intervention
- How many people
- 400 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Sep 2026to 15 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Canada2 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Karolina Kogut, BA., MPH., (403) 955-7211, kkogut@ucalgary.ca
Mary Brindle, MD, MPH
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Tabina A Ahmed, BSc., MSc., 416-813-7654 ext. 302196, tabina.ahmed@sickkids.ca
Eveline Lapidus-Krol, BSc., MSc., 416-813-6542 ext. 306542, eveline.lapidus-krol@sickkids.ca
United Kingdom1 site
Great Ormond Street Hospital
London, Greater London, WC1N 3BH
David de Beer, MB ChB, FRCA, +44 (0)20 3965 9900, David.DeBeer@gosh.nhs.uk
David de Beer, MB ChB, FRCA
About this study
Official title: Implementing Enhanced Recovery After Surgery (ERAS) for Neonates Undergoing Major Surgery: A Prospective Multicenter Stepped-Wedge Cluster Hybrid Effectiveness-Implementation Study
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Pre-nERAS Guideline Implementation Intervention, Multifaceted Implementation of nERAS Guideline Intervention
- Keywords
- Enhanced Recovery After Surgery, Neonatal surgery, Perioperative care, NICU, Guideline implementation, Guideline effectiveness, Neurodevelopmental outcomes, Neonatal ERAS, ERAS, Surgery
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-nERAS Guideline Implementation InterventionOther
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.
Multifaceted Implementation of nERAS Guideline InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pre-nERAS Guideline Implementation Intervention | |
| 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. Receives: Other: Multifaceted Implementation of nERAS Guideline Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Secondary outcomes (31)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: Retrospective chart review up to 1-year post-operatively.
Number of Patient Readmissions
Number of patients being re-admitted after index hospitalization/discharge.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Retrospective chart using standardized definitions at term/18-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neonatal Patients Undergoing Major Non-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
- Responsible party
- Principal investigator, Mercedes Pilkington, The Hospital for Sick Children
- Investigators
- Mercedes Pilkington, MD, MGSC, FRCSC, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771478
- Sponsor's protocol ID
- 6210101517
- Other IDs
- PJT 198180
- Acronym
- NEO
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified and pooled IPD used in the results for publications will be shared.
Publications
Pentz B, Short K, Pilkington M, Marchand T, Aziz S, Lam JY, Spencer A, Brockel MA, Else S, McLuckie D, Franklin A, de Beer D, Raval MV, Scott M, Brindle ME. Enhanced Recovery After Surgery (ERAS) consensus recommendations for non-pharmacological perioperative neonatal pain management. BMJ Paediatr Open. 2025 May 7;9(1):e003280. doi: 10.1136/bmjpo-2024-003280.
PubMed 40340819Pilkington M, Pentz B, Short K, Marchand T, Aziz S, Lam JY, Spencer A, Brockel MA, Else S, McLuckie D, Franklin A, de Beer D, Raval MV, Scott M, Brindle ME. Enhanced Recovery After Surgery (ERAS) consensus recommendations for opioid-minimising pharmacological neonatal pain management. BMJ Paediatr Open. 2024 Oct 8;8(1):e002824. doi: 10.1136/bmjpo-2024-002824.
PubMed 39384309Pilkington M, Pentz B, Lam JY, Stephen L, Howlett A, Theam M, Unrau J, McLuckie D, Else S, Brindle ME. Bringing Enhanced Recovery After Surgery to the NICU: An Implementation Trial. J Pediatr Surg. 2024 Apr;59(4):557-565. doi: 10.1016/j.jpedsurg.2023.11.025. Epub 2023 Dec 19.
PubMed 38185540Pentz B, Patel P, Pilkington M, Daodu O, Lam JYK, Howlett A, Stephen L, Spencer A, Unrau J, Theam M, Brindle ME. Optimizing Implementation of the Neonatal Enhanced Recovery After Surgery Guideline. J Pediatr Surg. 2025 Feb;60(2):161613. doi: 10.1016/j.jpedsurg.2024.06.021. Epub 2024 Jul 6.
PubMed 39068053Pilkington M, Nelson G, Pentz B, Marchand T, Lloyd E, Chiu PPL, de Beer D, de Silva N, Else S, Fecteau A, Giuliani S, Hannam S, Howlett A, Lee KS, Levin D, O'Rourke L, Stephen L, Wilson L, Brindle ME. Enhanced Recovery After Surgery (ERAS) Society Recommendations for Neonatal Perioperative Care. JAMA Surg. 2024 Sep 1;159(9):1071-1078. doi: 10.1001/jamasurg.2024.2044.
PubMed 39083294
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Enhanced Recovery After Surgery (ERAS) for Neonates Undergoing Major Surgery: A Prospective Multicenter Stepped-Wedge Cluster Hybrid Effectiveness-Implementation Study
- ClinicalTrials.gov ID
- NCT07771478
- Acronym / sponsor ID
- NEO / 6210101517
- Keywords
- Enhanced Recovery After Surgery, Neonatal surgery, Perioperative care, NICU, Guideline implementation, Guideline effectiveness, Neurodevelopmental outcomes, Neonatal ERAS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation Cohort: Standard Care | – | Other: Pre-nERAS Guideline Implementation InterventionNo 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. |
| Active Implementation Cohort | – | Other: Multifaceted Implementation of nERAS Guideline InterventionA 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. |
Who may qualify
- Ages
- 24 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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)
- Healthcare providers (surgeons, anesthesiologists, neonatologists, and nurses) who provide direct care for eligible infants described above
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-nERAS Guideline Implementation InterventionNeonates 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. | Other | Pre-Implementation Cohort: Standard Care |
| Multifaceted Implementation of nERAS Guideline InterventionThe 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. | Other | Active Implementation Cohort |
Primary outcome
Perioperative Management (POM) Score
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
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
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.
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.
31 secondary outcomes
Neurodevelopmental Outcomes: Bayley Scales of Infant and Toddler Development, 4th Edition (BSID-IV)
Time frame: 18-months corrected age
Number of Participants 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
Time frame: Retrospective chart review using standardized definitions within 30-days of surgery
Number of Participants with Unplanned reoperation
Time frame: Retrospective chart review using standardized definitions within 30-days of surgery, and 1-year of surgery.
Number of Participants with Opioid Use
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
Time frame: Retrospective chart review within 30-days and 1-year of surgery.
Index NICU Length of Stay
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
Time frame: Retrospective chart review up to 1-year post-operatively.
Number of Patient Readmissions
Time frame: Retrospective chart review at hospital of index presentation within 30-days of discharge.
Neurodevelopmental Outcomes: Hammersmith Infant Neurological Examination (HINE) Score
Time frame: 4-months corrected gestational age (cGA) for HINE
Neurodevelopmental Outcomes: Alberta Fine Motor Scale (AIMS)
Time frame: 4 + 8 + 12-months cGA for AIMS
Neurodevelopmental Outcomes: Posture and Fine Motor Assessment (PFMA)
Time frame: 8 + 12months cGA for PFMA
Implementation Readiness: Atlas Context Assessments
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
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
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
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
Time frame: Performed during active implementation (6-12 months of the study) of nERAS guidelines
Appropriateness of Intervention (IAM): 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)
Time frame: Retrospective chart review using standardized definitions up to 30-days post-operatively
Number of Central Line Days (Additional Exploratory Outcome)
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively
Number of Days to Full Enteral Feeds (Additional Exploratory Outcome)
Time frame: Retrospective chart using standardized definitions up to 1-year post-operatively
Number of Days of Supplemental Respiratory Support (Additional Exploratory Outcome)
Time frame: Retrospective chart using standardized definitions up to 1-year post-operatively
Number of Patients with Necrotizing Enterocolitis (Additional Exploratory Outcome)
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively
Number of Patients receiving Breastmilk at Discharge (Additional Exploratory Outcome)
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively
Growth Parameters: Head circumference (Additional Exploratory Outcome)
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively
Growth Parameters: Length (Additional Exploratory Outcome)
Time frame: Retrospective chart using standardized definitions up to 30-days post-operatively, and measured at birth.
Growth Parameters: Weight (Additional Exploratory Outcome)
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
Time frame: Retrospective chart using standardized definitions at discharge and up to 1-year post-operatively
Number of Patients with Total Parenteral Nutrition (TPN)
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
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
Time frame: Retrospective chart using standardized definitions at term/18-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 40340819Pentz B, Short K, Pilkington M, Marchand T, Aziz S, Lam JY, Spencer A, Brockel MA, Else S, McLuckie D, Franklin A, de Beer D, Raval MV, Scott M, Brindle ME. Enhanced Recovery After Surgery (ERAS) consensus recommendations for non-pharmacological perioperative neonatal pain management. BMJ Paediatr Open. 2025 May 7;9(1):e003280. doi: 10.1136/bmjpo-2024-003280.
- Background: PubMed 39384309Pilkington M, Pentz B, Short K, Marchand T, Aziz S, Lam JY, Spencer A, Brockel MA, Else S, McLuckie D, Franklin A, de Beer D, Raval MV, Scott M, Brindle ME. Enhanced Recovery After Surgery (ERAS) consensus recommendations for opioid-minimising pharmacological neonatal pain management. BMJ Paediatr Open. 2024 Oct 8;8(1):e002824. doi: 10.1136/bmjpo-2024-002824.
- Background: PubMed 38185540Pilkington M, Pentz B, Lam JY, Stephen L, Howlett A, Theam M, Unrau J, McLuckie D, Else S, Brindle ME. Bringing Enhanced Recovery After Surgery to the NICU: An Implementation Trial. J Pediatr Surg. 2024 Apr;59(4):557-565. doi: 10.1016/j.jpedsurg.2023.11.025. Epub 2023 Dec 19.
- Background: PubMed 39068053Pentz B, Patel P, Pilkington M, Daodu O, Lam JYK, Howlett A, Stephen L, Spencer A, Unrau J, Theam M, Brindle ME. Optimizing Implementation of the Neonatal Enhanced Recovery After Surgery Guideline. J Pediatr Surg. 2025 Feb;60(2):161613. doi: 10.1016/j.jpedsurg.2024.06.021. Epub 2024 Jul 6.
- Background: PubMed 39083294Pilkington M, Nelson G, Pentz B, Marchand T, Lloyd E, Chiu PPL, de Beer D, de Silva N, Else S, Fecteau A, Giuliani S, Hannam S, Howlett A, Lee KS, Levin D, O'Rourke L, Stephen L, Wilson L, Brindle ME. Enhanced Recovery After Surgery (ERAS) Society Recommendations for Neonatal Perioperative Care. JAMA Surg. 2024 Sep 1;159(9):1071-1078. doi: 10.1001/jamasurg.2024.2044.
- Individual participant dataSharing planned: No. Only de-identified and pooled IPD used in the results for publications will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mercedes Pilkington, MD, MGSC, FRCSC principal investigator
The Hospital for Sick Children
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Patients Undergoing Major Non-cardiac Surgery and Congenital Anomaly, run by The Hospital for Sick Children at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tabina A Ahmed, BSc., MSc. (416-813-7654 ext. 302196, tabina.ahmed@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Management (POM) Score (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07771478, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.