P1.073: Refining Inclusion and Exclusion Criteria for an Enhanced Recovery Protocol for Neonates/Infants Undergoing Intestinal Surgery

Background: Although the Enhanced Recovery After Surgery (ERAS®) Society published guidelines for perioperative care in neonatal intestinal surgery in 2020, adoption has lagged. Through stakeholder focus groups, we previously identified key barriers to adoption, including an imprecisely defined eligible patient population. This study sought to refine patient inclusion and exclusion criteria for a Neonatal/Infant Intestinal Surgery Enhanced Recovery Protocol (ERP) to be tested in a future trial.

Methods: As part of a modified Delphi process, two Qualtrics surveys were sent to 44 stakeholders (neonatologists, surgeons, anesthesiologists, nurses, QI representatives, and caregivers of patients) at six geographically diverse hospitals. Using a 3-point Likert scale (include, possibly include, exclude) and free-text comments, we elicited perspectives on inclusion and exclusion criteria by surgery type (e.g., elective, emergent), procedure (e.g., ileal atresia repair, ostomy reversal), concurrent surgery, gestational age, age at surgery, weight at surgery, and comorbidities. Consensus was defined as >/=70% of respondents selecting “include.” During the first round, if >30% answered “exclude,” the criterion was omitted from the subsequent round.

Results: In Round 1, 36 (82%) respondents included patients born at >/=32 weeks gestation, >/=4 weeks old at surgery, weighing >/=1.5kg, and undergoing elective surgery (e.g., bowel resection, ostomy creation/reversal). Respondents excluded patients born extremely pre-term ( < 28 weeks), weighing < 1kg, undergoing emergent surgery, undergoing concurrent cardiac surgery, on extracorporeal membrane oxygenation support, or with severe coagulopathies. In Round 2, 33 (75%) respondents included patients aged < 1y at surgery, procedures including duodenal and Type I-IIIA atresia repairs, surgery concurrent with neurosurgical and orthopedic procedures, and patients with lower risk cardiac conditions, chromosomal abnormalities, Hirschsprung’s disease, anorectal malformation, or neonatal respiratory distress requiring intubation. Patients < 1.5kg, born very preterm (28-32 weeks), undergoing Type IIIB-IV atresia repairs, undergoing surgery concurrent with a tracheostomy, or with any other co-morbidities were excluded. Results from both surveys were merged to refine the eligible patient population (FIGURE).

Conclusion: Using a modified Delphi process, we successfully refined patient inclusion and exclusion criteria for a Neonatal/Infant Intestinal Surgery ERP. With these consensus-based inclusion and exclusion criteria, we have identified an appropriate, acceptable cohort for a future implementation and effectiveness trial of the ERP.