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Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study

Study acronym: NEO
StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Notable Start date pushed from Aug 3, 2026 to Sep 30, 2026 Show 5 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 15 of 31 entries
    • Site details revised at 1 of 3 sites
    • Collaborators: details revised at 1 of 2 entries
    • Publications: details revised at 5 of 5 entries
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07771478
Lead Sponsor The Hospital for Sick Children
Collaborators: Alberta Children's Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
Conditions
(from sponsor)
Neonatal Patients Undergoing Major Non-cardiac Surgery, Congenital Anomaly
Related terms Congenital Abnormalities
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov