Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study

NCT07771478 | Not Yet Recruiting

• 2 other identifiers: 6210101517PJT 198180
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 3

Brief 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 improve recovery. This study has three main goals:

1. 1.To evaluate whether the nERAS guidelines improve short-term health outcomes for newborns who need major surgery,
2. 2.To understand how well the guidelines are adopted and followed by healthcare teams,
3. 3.To study longer-term development outcomes (up to 18 months after surgery) for a group of babies treated under this care pathway.

Conditions

Congenital Anomaly; Neonatal Patients Undergoing Major Non-cardiac Surgery

Keywords

Enhanced Recovery After Surgery; Neonatal surgery; Perioperative care; NICU; Guideline implementation; Guideline effectiveness; Neurodevelopmental outcomes; Neonatal ERAS; ERAS; Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (31)

• Neurodevelopmental Outcomes: Bayley Scales of Infant and Toddler Development, 4th Edition (BSID-IV)

  18-months corrected age

• Number of Participants with Surgical Site Infections (SSIs)

  This outcome will be measured via retrospective chart review using standardized definitions within 30-days of surgery.

• Number of Participants with Sepsis

  Retrospective chart review using standardized definitions within 30-days of surgery

• Number of Participants with Unplanned reoperation

  Retrospective chart review using standardized definitions within 30-days of surgery, and 1-year of surgery.

• Number of Participants with Opioid Use

  Retrospective chart review of cumulative dose, days on narcotics, narcotic prescription on discharge, cumulative dose of narcotics within first 7 days after surgery, and number of days of post-operative narcotic-use (30-days post-operatively).

Other Outcomes (31)

• Primary surgical diagnosis

  Retrospective chart review up to 7-days post-operatively.

• Urgency of surgery

  Retrospective chart review up to 7-days post-operatively.

• Invasiveness of surgery

  Retrospective chart review up to 7-days post-operatively.

Study Arms (2)

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

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

Interventions

Pre-nERAS Guideline Implementation Intervention OTHER

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.

Pre-Implementation Cohort: Standard Care

Multifaceted Implementation of nERAS Guideline Intervention OTHER

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.

Active Implementation Cohort

Eligibility Criteria

• Age: 24 Weeks - 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Alberta Children's Hospital: collaborator
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator

Study Sites (3)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Great Ormond Street Hospital

London, Greater London, WC1N 3BH, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 40340819 BACKGROUND

• 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.

  PMID: 39384309 BACKGROUND

• 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.

  PMID: 38185540 BACKGROUND

• 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.

  PMID: 39068053 BACKGROUND

• 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.

  PMID: 39083294 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mercedes Pilkington, MD, MGSC, FRCSC

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tabina A Ahmed, BSc., MSc.

CONTACT

416-813-7654; tabina.ahmed@sickkids.ca

Eveline Lapidus-Krol, BSc., MSc.

CONTACT

416-813-6542; eveline.lapidus-krol@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Surgeon, Division of General and Thoracic Surgery, Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: August 18, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): December 15, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); GB (1)