Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study

ConditionsNeonatal Patients Undergoing Major Non-cardiac Surgery Congenital Anomaly

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age24-44

SponsorThe Hospital for Sick Children

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Pre-nERAS Guideline Implementation Intervention
Other 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.
Multifaceted Implementation of nERAS Guideline Intervention
Other 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.

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: Pre-Implementation Cohort: Standard Care1 intervention

Group B: Active Implementation Cohort1 intervention

Trial outcomes

Primary outcomes

Perioperative Management (POM) Score

The investigators will use the Perioperative Management Score (temperature, pH, pCO2, glucose, and unintended respiratory events) to measure clinical effectiveness of nERAS and reflect perioperative stability and recovery pre-implementation and during active- implementation of nERAS. The POM Score was developed by the Children's Hospital Neonatal Consortium using relevant literature and expert review. It provides a pragmatic objective measure of neonatal physiologic status after surgery using investigations that are completed as part of routine clinical care. This measure also directly reflects at least 50% of the recommendations in nERAS (temperature regulation, perioperative ventilation, fluid management, perioperative glucose control, transfusion thresholds, and team communication).

Time frame

The POM Score is derived from: blood tests within one hour after surgery, body temperature (measured within one hour of return to NICU from surgery), and unintended respiratory events within the first 24 hours post-operatively

Adoption of nERAS

Through retrospective chart review and using standardized definitions (i.e. primary and secondary outcomes from the effectiveness arm of the NEO Study), this outcome will assess concordance between care provided and evidence-based guideline recommended care.

Time frame

Outcome will be measured within 30-days of surgery, prior to structured implementation, during active implementation, and during sustainability audits at 6 and 12-months after active-implementation of nERAS has been completed.

Secondary outcomes

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

A nested single-center cohort of prospectively enrolled infants undergoing major noncardiac surgery will examine whether nERAS implementation are measured (feasibility) and whether there is an impact on NDI at 18-month corrected age. All infants at HSC who undergo standardized neurodevelopmental follow-up as part of routine care after hospital discharge will be included. The primary outcome of NDI is defined as any grade cerebral palsy or composite motor scores below 2 standard deviations as measured by the Bayley Scales of Infant and Toddler Development, 4th Edition (BSID-IV) at 18 months corrected age. BSID-IV is a comprehensive, standardized neurodevelopmental assessment tool with high reliability for evaluating developmental delays in infants and toddlers.

Time frame

18-months corrected age

Number of Participants with Surgical Site Infections (SSIs)

Core surgical complication measuring the number of patients with surgical site infections (SSIs).

Time frame

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

Number of Participants with Sepsis

Core neonatal clinical outcome measuring the number of participants with sepsis, alongside details of blood cultures ordered.

Time frame

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

Number of Participants with Unplanned reoperation

Core surgical complication measuring the number of participants with unplanned reoperation, alongside details on whether the procedure performed was a surgery or a drain.

Time frame

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

Other outcomes

Primary surgical diagnosis

The primary surgical diagnosis of the patient will be recorded pre-operatively and post-operatively. Options include Necrotizing enterocolitis (NEC)/Intestinal perforation, Bowel obstruction, Intestinal atresia, Esophageal atresia with or without fistula (EA+/-TEF), Congenital diaphragmatic hernia (CDH), Anorectal malformation (ARM), Abdominal wall defect (gastroschisis, omphalocele), Malrotation, and/or Hydrocephalus. Investigators will also record other primary diagnoses not included in this preliminary list, if any.

Time frame

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

Urgency of surgery

Investigators will retrospectively collect data on whether or not the surgery performed was urgent, emergency, or elective.

Time frame

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

Invasiveness of surgery

Investigators will retrospectively collect information on whether or not the surgery was a minimally invasive surgery (MIS), an open surgery, or a converting surgery (MIS to open).

Time frame

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

Comorbidities at the time of surgery

Information regarding the type and details of comorbidities will be recorded (i.e. gastrointestinal, neurological, cardiovascular, respiratory, heme, genetic, or other)

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hospital for Sick Children

Lead sponsor

Alberta Children's Hospital

Collaborator

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

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