Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study

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. 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.

Conditions

• Neonatal Patients Undergoing Major Non-cardiac Surgery
• Congenital Anomaly

Interventions

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.

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.

Sponsors & Collaborators

• Alberta Children's Hospital

  collaborator OTHER

• Great Ormond Street Hospital for Children NHS Foundation Trust

  collaborator OTHER

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Mercedes Pilkington, MD, MGSC, FRCSC · The Hospital for Sick Children

Eligibility

Min Age

24 Weeks

Max Age

44 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-03

Primary Completion

2029-06-15

Completion

2029-12-15

Countries

• Canada
• United Kingdom

Study Locations