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Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients

Study acronym: i-DETECT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Sep 22, 2023 to Jan 7, 2025v9
  2. Study completion moved earlier from Jul 31, 2027 to Jun 30, 2027
    • Primary completion date: Jul 1, 2027 to Jun 30, 2027
    • Start date: Jan 7, 2025 to Sep 22, 2023
    v8
  3. Primary completion date: Jan 1, 2027 to Jul 1, 2027v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2025 to Jan 7, 2025
    • Site details revised at 4 of 4 sites
    v6
  5. Start date: Jul 1, 2024 to Mar 1, 2025
    • Study description expanded, about 672 words
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Primary completion date: Jul 2027 to Jan 1, 2027v3
  3. Start date: May 2024 to Jul 1, 2024
    • Enrollment target: 380 to 500
    • Primary completion date: Dec 2027 to Jul 2027
    • Study completion date: Jun 2028 to Jul 31, 2027
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to analyze Fitbit data to predict infection after surgery for complicated appendicitis and the effect this prediction has on clinician decision making.
Trial Details
NCT Number NCT06395636
Lead Sponsor Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators: Northwestern University, Central DuPage Hospital, University of Chicago, Loyola University Chicago
Conditions
(from sponsor)		 Appendectomy, Appendicitis, Appendicitis Acute
Related terms Appendicitis, Infections
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov