Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study

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).

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.

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.

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

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

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

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.

Core neonatal clinical outcome measuring the number of mortalities in the study cohort at 30-day follow-up, and 1-year follow-up.

Number of days spent in the NICU (total and post-operatively).

Number of days spent in hospital (total and post-operatively)

Number of patients being re-admitted after index hospitalization/discharge.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Number of patients that had been re-intubated post-operatively.

Total number of days that patients have a central venous catheter in place.

Number of days on full enteral feeds, intra-operatively and up to 1-year post-operatively.

Number of patients on supplemental respiratory support

Total number of patients with a diagnosis of necrotizing enterocolitis.

Core neonatal clinical outcome measuring the number of patients receiving breastmilk post-operatively/at discharge.

Head circumference will be measured as percentile and z-scores, in centimeters (cm).

Length will be measured as percentile and z-scores, in centimeters (cm).

Weight will be measured as percentile and z-scores, in centimeters (cm).

Number of patients receiving tube feeding post-operatively/at discharge

Number of patients receiving TPN intra-operatively/1-year post-surgery

Core neonatal clinical outcome representing confirmed diagnoses of brain injuries detected via Head Ultrasound pre/post-operatively.

Core neonatal clinical outcome representing confirmed diagnoses of brain injuries via Head MRI.