ClinicalTrials.gg
RecruitingNCT06395636i-DETECTUpdated May 13, 2026

Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients

An interventional study of Infection-Prediction Algorithm in Appendectomy, Appendicitis and Appendicitis Acute, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Recruiting at 4 sites in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Non-randomized
Ages
3 Years to 18 Years
Sex
All
01

Study summary

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.

Read the detailed description

We propose to investigate the use of objective near-real time data from the Fitbit consumer wearable device (CWD) for early detection of postoperative infection in children after appendectomy for complicated appendicitis, and its influence on clinician decision-making, time to first contact with the healthcare system, and postoperative healthcare use. SSI is usually associated with increased heart rate (HR) and reduced physical activity (PA), and sleep disturbances due to discomfort, pain, and fever.13-15 To help monitor patients post-discharge, CDWs can be used to detect physiologic changes, prompting early management.16,17 CWDs generate continuous, valid HR data comparable to clinical-grade HR monitor data for children, as well as objective PA and sleep data, which are good indicators of recovery.18-21 CWDs, then transmit these data in near-real time to a cloud-based system potentially accessible to a clinician. Although health systems have incorporated CWD data into electronic health records,16,17 use in post-discharge monitoring of pediatric surgery patients has been limited18 since it is difficult to monitor and interpret the large volumes of data generated by CWD in clinically meaningful ways.18 Machine learning (ML) methods, which reduce CWD data into clinically meaningful signals are needed.22 Since these algorithms are based on data from multiple CWD sensors, they are more accurate than threshold-based alerts.

We collected Fitbit data on 160 pediatric appendectomy patients21,23,24 and showed slower normative recovery PA trajectories in children with complicated versus simple appendicitis, and deviations from normative PA trajectory (decreased PA) before parents sought healthcare for complications.20 We then applied ML methods to Fitbit data of 80 post appendectomy patients with complicated appendicitis to predict infection. The preliminary algorithm predicted 90% of infections, 2 days before parental report. In parallel, we developed a proof-of-concept dashboard that delivers Fitbit data daily and on-demand in near real-time to clinicians. Using the dashboard, clinicians evaluated hypothetical post-discharge pediatric appendectomy scenarios with and without Fitbit dashboard data. Availability of Fitbit data (even without ML) substantially changed clinicians' likelihood of recommending ED care. While our early results are promising, a larger study is needed to definitively elucidate the association of changes in Fitbit data with postoperative infection and to assess the effect of Fitbit data on clinician decision-making and healthcare use. We propose to develop a ML algorithm for postoperative infection using Fitbit data of children 3-18 years old undergoing a appendectomy for complicated appendicitis at the Ann and Robert H. Lurie Children's Hospital of Chicago (LCH), a tertiary care children's hospital and two affiliated hospitals Loyola University Medical Center, a university hospital), and Central DuPage Hospital (CDH), a community hospital. Our two aims are:

Aim 1: Develop and externally validate an ML algorithm for postoperative infection. In addition to the 80 patients already recruited in our preliminary study, we will prospectively recruit 170 patients for a total of 250 from LCH for development and internal validation. We will then externally validate our infection ML algorithm using data on 122 appendectomy patients from LCH and its two affiliates.

Aim 2: Conduct a pre-post study to determine the effect of near real-time availability of the infection alert from Fitbit on clinical decision-making, time to first contact with the healthcare system, and healthcare utilization. We will place a Fitbit on 94 children after appendectomy recruited from LCH and its two affiliates, and send their surgeons daily reports of their recovery progress and near real-time, ML-based, clinical alerts of infection. In Aim 2a, we will use critical incident technique to qualitatively assess surgeons' decision-making after receiving Fitbit alerts and daily reports. In Aim 2b, we will compare median time to first contact with the healthcare system, healthcare use patterns (e.g., ED visits) and costs pre and post receiving alerts and daily reports.

Impact: This study is well aligned with NINR's priority to advance symptoms science. Developing CWD alerts to detect infection and evaluating their effect on clinical care have the potential to transform pediatric surgical care and pave the way for wide uptake of CWD. By proactively reaching to patients, this technology also has the potential to reduce existing disparities in seeking care.

02

Conditions studied

  • Appendectomy
  • Appendicitis
  • Appendicitis Acute

Keywords

  • consumer wearables
  • machine learning
  • ML
  • Fitbit
  • infection
  • detection
  • algorithm
  • prediction
03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's planned enrollment of 500 is above the median of 111 across 252 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 180 studies on the registry; 28 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • children aged 3-18 years
  • must be post-surgical laparoscopic appendectomy for complicated appendicitis (Appendicitis is categorized as complicated if perforation, phlegmon, or abscess was present at surgery.)

Exclusion criteria

Exclusion Criteria:

  • children who are non-ambulatory or have any pre-existing mobility limitations
  • children who have a doctor-ordered physical activity limit \>48 hours post-surgery
  • children who have a comorbidity which will impact a patient's recovery
  • children and/or parents who do not speak English or Spanish (Translation services beyond Spanish will not be available at this time)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • No intervention
    Aim 1 - Validation

    1a. Development and Internal validation * analyze Fitbit data (PA, HR, sleep) by applying ML methods to create an infection algorithm indicating onset of infection. 1b. External Validation * Once the ML classifier has been internally validated (using Lurie Children's data only) for its ability to detect the presence or absence of postoperative infection using LOSO cross-validation, where each subject is iteratively held out from the training data and used as a test set. External validation will involve applying this classifier to a newer cohort at LCH and cohorts at Loyola University Hospital and CDH and evaluating its performance.

  • Experimental
    Aim 2 - Implementation of Algorithm

    2a. Exploratory \& Inductive analysis * one transcript will be coded to generate initial themes, using qualitative analytic software 2b. Time to first contact with the healthcare system \& Healthcare use * Cox regression model will be used to model the time to first contact, adjusted for covariates * All comparisons between the two groups will be tested using a chi-square test. Cost will be modeled as a continuous variable and is expected to be skewed, as is typical of cost data. We will use a general linear model (GLM) to model cost outcomes.

    Device: Infection-Prediction Algorithm

Interventions

  • DeviceInfection-Prediction Algorithm

    This machine learning algorithm will be developed(Aim1a) and validated(Aim 1b) using the participant Fitbit data and survey results collected during Aim 1. In Aim 2 the algorithm will be used in real time to predict postoperative infection.

06

What researchers measure

Primary outcomes

  1. Trends in Participant Fitbit Data (Physical Activity, Heart Rate, Sleep) during the Recovery Period post Complicated Appendectomy

    Participant Fitbit data metrics (particularly PA, HR, Sleep) will be extracted from the app and analyzed using Machine Learning methods to eventually develop an algorithm to predict infection during the postoperative recovery period.

    Time frame: Fitbit data metrics will be collected for 30 days starting at date of enrollment.

Secondary outcomes

  1. Number of Reported Symptoms and Complications during Recovery

    Participants \& Parents/Guardians will report any symptoms or complications that occur during the recovery period via a daily diary/survey.

    Time frame: Daily Diary/Survey Submissions will be asked to be completed daily for 30 days starting day of enrollment.

  2. Healthcare Utilizations during Recovery Period

    The daily diary/survey will also ask Parents / Guardians of any trips to the ER, readmissions, or hospital visits relating to the participant's appendectomy.

    Time frame: The diary / survey will require a submission every day for 30 days starting at day of enrollment.

  3. Change in Clinician Decision Making from Algorithm Results

    Clinicians of participants (Aim 2) will be asked if the results from the infection prediction algorithm had any impact on their clinical care decisions.

    Time frame: For 30 days starting at day of participant enrollment

07

Study locations

2 of 4 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Jun 2027, 29 months after the start.

Of 89 non-industry interventional studies with no phase under Appendicitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 29 months is above that.

Counting every sponsor, half of 91 studies reached it within 18 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2024
First posted
May 2, 2024
StartActual
Jan 7, 2025
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
May 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06395636
Collaborators
Northwestern University, Central DuPage Hospital, University of Chicago, Loyola University Chicago
Responsible party
Fizan Abdullah, MD, PhD (Fizan Abdullah M.D., Ph.D, Ann & Robert H Lurie Children's Hospital of Chicago) — Principal investigator
First posted
May 2, 2024
Start date
Jan 7, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
May 13, 2026

Study contacts

Fizan Abdullah, MD, PhD
Contact
fabdullah@luriechildrens.org
312-227-4210
Arianna Edobor, CRC
Contact
idetect@luriechildrens.org
312-227-2118
Fizan Abdullah, MD, PhD
principal investigator · Ann & Robert H Lurie Children's Hospital of Chicago
Hassan Ghomrawi, PhD, MPH
principal investigator · University of Alabama at Birmingham
Arun Jayaraman, PT, PhD
principal investigator · Shirley Ryan AbilityLab

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion