Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study (NEO)

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:

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Anomaly; Neonatal Patients Undergoing Major Non-cardiac Surgery
• Intervention / Treatment: Other: Pre-nERAS Guideline Implementation Intervention; Other: Multifaceted Implementation of nERAS Guideline Intervention

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Tabina A Ahmed, BSc., MSc.; Phone Number: 302196 416-813-7654; Email: tabina.ahmed@sickkids.ca
• Study Contact Backup: Name: Eveline Lapidus-Krol, BSc., MSc.; Phone Number: 306542 416-813-6542; Email: eveline.lapidus-krol@sickkids.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Alberta Children's Hospital
      • Contact: Karolina Kogut, BA., MPH.; Phone Number: (403) 955-7211; Email: kkogut@ucalgary.ca
      • Principal Investigator: Mary Brindle, MD, MPH
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
      • Contact: Tabina A Ahmed, BSc., MSc.; Phone Number: 302196 416-813-7654; Email: tabina.ahmed@sickkids.ca
      • Contact: Eveline Lapidus-Krol, BSc., MSc.; Phone Number: 306542 416-813-6542; Email: eveline.lapidus-krol@sickkids.ca
      • Principal Investigator: Mercedes Pilkington, MD, MGSC, FRCSC
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, WC1N 3BH
      • Great Ormond Street Hospital
      • Contact: David de Beer, MB ChB, FRCA; Phone Number: +44 (0)20 3965 9900; Email: David.DeBeer@gosh.nhs.uk
      • Principal Investigator: David de Beer, MB ChB, FRCA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria

Effectiveness aims:

• Consent provided by parent/legal guardian
• Infant aged ≥24 weeks gestational age at birth and <cGA 44 weeks at time of index surgery
• Requires major non-cardiac surgery requiring general anesthetic (e.g., thoracotomy, laparotomy, ventriculoperitoneal shunt, choanal atresia repair, etc.)
• Admitted preoperatively to a study NICU (HSC, ACH, or GOSH)

Implementation aims:

• Healthcare providers (surgeons, anesthesiologists, neonatologists, and nurses) who provide direct care for eligible infants described above
• Caregivers of eligible infants described above (caregiver role to be defined by family and may include parent(s) and/or extended family members)

Exclusion Criteria

Effectiveness aims:

• Infants undergoing cardiac surgery as sole index surgical intervention, sole minor index surgery (e.g., central line placement, eye exam under anesthesia)
• Born at less than 24 weeks estimated gestational age or greater than 44 weeks corrected gestation age on day of index surgery
• Intraoperative mortality
• Genetic anomaly associated with lethality (e.g., trisomy 13 or 18)
• Preoperative ECMO (extra-corporeal membrane oxygenation) cannulation
• Fetal intervention (e.g, FETO for CDH)

Implementation aims:

- Healthcare providers and/or caregivers who do not consent to participate in Implementation surveys or interviews.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Pre-nERAS Guideline Implementation 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.
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.	Other: Multifaceted Implementation of nERAS Guideline Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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.	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.	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).	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)	Retrospective chart review up to 1-year post-operatively.
Number of Patient Readmissions	Number of patients being re-admitted after index hospitalization/discharge.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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.	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.	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).	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).	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).	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	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	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.	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.	Retrospective chart using standardized definitions at term/18-month follow-up.

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Alberta Children's Hospital; Great Ormond Street Hospital for Children NHS Foundation Trust
• Investigators: Principal Investigator: Mercedes Pilkington, MD, MGSC, FRCSC, The Hospital for Sick Children

Publications and helpful links

General 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.
• Pilkington 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.
• Pilkington 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.
• Pentz 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.
• Pilkington 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): December 15, 2029

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: August 14, 2026
• First Posted (Actual): August 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Surgery; Perioperative care; Enhanced Recovery After Surgery; NICU; ERAS; Neonatal surgery; Neurodevelopmental outcomes; Guideline implementation; Guideline effectiveness; Neonatal ERAS
• Additional Relevant MeSH Terms: Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Congenital Abnormalities
• Other Study ID Numbers: 6210101517; PJT 198180 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only de-identified and pooled IPD used in the results for publications will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No