Healthy Children (1 Month to 17 Years Old)CapAppNCT05472116
Capillary Refill Time Measurement Utilizing Mobile Application in Children
An observational study of Healthy Children (1 Month to 17 Years Old), run by University of Minnesota at 1 site in United States.
Trial summary
To determine the accuracy and precision of capillary refill time measurement using a mobile health application (Cap App) in a healthy pediatric population. This will be a cross-sectional study measuring the capillary refill time in a healthy pediatric population using both the Cap App and two additional manual methods… Read more about this study
- Who is it for?
- Ages 1 month to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children (1 Month to 17 Years Old)
- What is being tested?
- Mobile Health application (CapApp)
- Type of treatment
- Medical device
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children age 1 month to 17 years
Who may be able to join
- Healthy children aged 1 month to 17 years
Who cannot join
- Fever or hypothermia
- Chronic illness including cardiovascular or renal disease
- Severe injury or blood loss
- Dehydration
- Raynaud's phenomenon
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
To determine the accuracy and precision of capillary refill time measurement using a mobile health application (Cap App) in a healthy pediatric population. This will be a cross-sectional study measuring the capillary refill time in a healthy pediatric population using both the Cap App and two additional manual methods which will serve as the comparison.
- Being tested
- Mobile Health application (CapApp)
- Keywords
- Capillary Refill, Mobile Health Application, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health application (CapApp)Device
Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App).
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and Precision of a Mobile Health Application (Cap App)
Capillary refill time (CRT) of Cap App compared to two manual methods
Measured: Time it takes for blood to return to issue on the fingertip after pressure application for 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start26 Aug 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Children (1 Month to 17 Years Old)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472116
- Sponsor's protocol ID
- pending2
- Acronym
- CapApp
- Status last verified
- May 2024
- First submitted
- 21 Jul 2022
- Last updated
- 22 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans on sharing results of the individual participant study data or aggregate study data with the participants. The data will be kept blinded from the research team members at the time of collection and, thus, no information will be shared with the participants.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capillary Refill Time Measurement Utilizing Mobile Application in Children
- ClinicalTrials.gov ID
- NCT05472116
- Acronym / sponsor ID
- CapApp / pending2
- Keywords
- Capillary Refill, Mobile Health Application, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Posted 22 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the accuracy and precision of capillary refill time measurement using a mobile health application (Cap App) in a healthy pediatric population. This will be a cross-sectional study measuring the capillary refill time in a healthy pediatric population using both the Cap App and two additional manual methods which will serve as the comparison.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children age 1 month to 17 years
Key inclusion criteria (1 listed)
- Healthy children aged 1 month to 17 years
Key exclusion criteria (5 listed)
- Fever or hypothermia
- Chronic illness including cardiovascular or renal disease
- Severe injury or blood loss
- Dehydration
- Raynaud's phenomenon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health application (CapApp)Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App). | Device | – |
Primary outcome
Accuracy and Precision of a Mobile Health Application (Cap App)
Time frame: Time it takes for blood to return to issue on the fingertip after pressure application for 5 seconds
Capillary refill time (CRT) of Cap App compared to two manual methods
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are no plans on sharing results of the individual participant study data or aggregate study data with the participants. The data will be kept blinded from the research team members at the time of collection and, thus, no information will be shared with the participants.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Children (1 Month to 17 Years Old), run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and Precision of a Mobile Health Application (Cap App) (time frame: Time it takes for blood to return to issue on the fingertip after pressure application for 5 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.