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Vomiting Prevention in Children With Cancer

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fields
  2. Minor Final enrollment: 1953 participants (planned 1332) Show 4 more changesShow less
    • Secondary endpoints: 4 to 3
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 2 words
    • Study description shortened, about 1 word
  3. Minor Enrollment closed, study ongoing
    • Primary completion date changed from estimate of Mar 18, 2027 to Sep 2, 2026
    • Site details revised
    v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  6. Minor Secondary endpoints: details revised at 2 of 4 entries
    • Study description shortened, about 26 words
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 single arm trial is to learn if a machine learning (ML) model predicting the risk of vomiting within the next 96 hours will impact vomiting outcomes in inpatient cancer pediatric patients. The main questions it aims to answer are whether an ML model predicting the risk of vomiting within the next 96 hours will: Primary 1\. Reduce the proportion with any vomiting within the 96-hour window Secondary 1. Reduce the number of vomiting episodes 2. Increase the proportion receiving care pathway-consistent care 3. Impact on specific antiemetic medication administrations Exploratory: To determine whether deployment of the ML model reduces the proportion of patients with any nausea within 96 hours and to characterize references to the algorithm in clinical notes following deployment, and to determine the number of times the prediction report dashboard was opened. Newly admitted participants will have a ML model predict the risk of vomiting within the next 96 hours according to their medical admission information. The prediction will be made at 8:30 AM following admission. Pharmacists will be charged with bringing information about patients' vomiting risk to the attention of the medical team and implementing interventions.
Trial Details
NCT Number NCT06886451
Lead Sponsor The Hospital for Sick Children
Conditions
(from sponsor)
Chemotherapy Induced Nausea and Vomiting, Quality of Life (QOL), Pediatric Cancer
Related terms Neoplasms, Vomiting
Enrollment 1,953 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov