Growth and DevelopmentNCT02805192
Validation of a Smart Phone App to Non-invasively Measure the Size of Children
A study testing Size Measurement by a Smart phone App in people with Growth and Development, run by University of Zurich at 1 site in Switzerland.
Trial summary
Smart phones are omnipresent. Apps exist to calculate size of medical equipment and doses of medication if a valid weight or age is entered. During emergency situations, these values are often unknown. An App has been developed to measure the size of a child noninvasively. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth and Development
- What is being tested?
- Size Measurement by a Smart phone App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 627 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jan 2016to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- male and female patients 0-12 years of age (45 per age group)
- obtained informed consent
- admitted to the emergency department of the Children's Hospital of the University of Zurich
Who cannot join
- physically or mentally unable for measurement
- denial of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Smart phones are omnipresent. Apps exist to calculate size of medical equipment and doses of medication if a valid weight or age is entered. During emergency situations, these values are often unknown. An App has been developed to measure the size of a child noninvasively. This App is now to be validated in clinical practice. App measured size is calculated and compared to the real size of a child. Via known percentiles of age/weight of the child is calculated upon the App measured size. This value is compared to the mother's, physician's and nurses estimation of the size and weight.
Depending on the size multiple algorithms exist to estimate weight, age and medical values. ("Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®"). These estimations by the calculations will also be compared to actual weight and age.
Children from 0-12 years of age are included in the emergency Department of the Children's Hospital of the University of Zurich after informed consent obtained by the parents. No therapy decisions from these calculations will be made. The therapy is independent of this study.
- Conditions
- Growth and Development
- Being tested
- Size Measurement by a Smart phone App
- Keywords
- Emergency Department, Estimation of age and weight, Size measurement
- Medical subject headings
- Emergencies, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Size Measurement by a Smart phone AppDevice
| Study group | Role | What they receive |
|---|---|---|
| one Arm: size measurement by Smart phone App | Other | Not described Receives: Device: Size Measurement by a Smart phone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the size measured by the smart phone app with the child's size.
Measured: immediate, no follow up
Secondary outcomes (3)
Comparison of the estimations calculated upon the smart phone measured size (via known percentiles) with the real age and weight.
Measured: immediate, no follow up
Comparison of estimations by "Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®" with real age and weight.
Measured: immediate, no follow up
Comparison of estimations by parents, physicians and nurses with the actual size and weight.
Measured: immediate, no follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start30 Jan 2016
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth and DevelopmentStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Stein, University of Zurich
- Investigators
- Donat R Spahn, M.D., F.R.C.A., Study chair, University and Universtity Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805192
- Sponsor's protocol ID
- KEK 2016-271, 94-2015
- Status last verified
- May 2017
- First submitted
- 10 Jun 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wetzel O, Schmidt AR, Seiler M, Scaramuzza D, Seifert B, Spahn DR, Stein P. A smartphone application to determine body length for body weight estimation in children: a prospective clinical trial. J Clin Monit Comput. 2018 Jun;32(3):571-578. doi: 10.1007/s10877-017-0041-z. Epub 2017 Jun 28.
PubMed 28660564
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Smart Phone App to Non-invasively Measure the Size of Children
- ClinicalTrials.gov ID
- NCT02805192
- Acronym / sponsor ID
- KEK 2016-271, 94-2015
- Conditions
- Growth and Development
- Keywords
- Emergency Department, Estimation of age and weight, Size measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 30 Jan 2016
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smart phones are omnipresent. Apps exist to calculate size of medical equipment and doses of medication if a valid weight or age is entered. During emergency situations, these values are often unknown. An App has been developed to measure the size of a child noninvasively. This App is now to be validated in clinical practice. App measured size is calculated and compared to the real size of a child. Via known percentiles of age/weight of the child is calculated upon the App measured size. This value is compared to the mother's, physician's and nurses estimation of the size and weight.
Depending on the size multiple algorithms exist to estimate weight, age and medical values. ("Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®"). These estimations by the calculations will also be compared to actual weight and age.
Children from 0-12 years of age are included in the emergency Department of the Children's Hospital of the University of Zurich after informed consent obtained by the parents. No therapy decisions from these calculations will be made. The therapy is independent of this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one Arm: size measurement by Smart phone App | Other | Device: Size Measurement by a Smart phone App |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- male and female patients 0-12 years of age (45 per age group)
- obtained informed consent
- admitted to the emergency department of the Children's Hospital of the University of Zurich
Key exclusion criteria (2 listed)
- physically or mentally unable for measurement
- denial of informed consent
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 |
|---|---|---|
| Size Measurement by a Smart phone App | Device | one Arm: size measurement by Smart phone App |
Primary outcome
Comparison of the size measured by the smart phone app with the child's size.
Time frame: immediate, no follow up
3 secondary outcomes
Comparison of the estimations calculated upon the smart phone measured size (via known percentiles) with the real age and weight.
Time frame: immediate, no follow up
Comparison of estimations by "Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®" with real age and weight.
Time frame: immediate, no follow up
Comparison of estimations by parents, physicians and nurses with the actual size and weight.
Time frame: immediate, no follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Derived from this study: PubMed 28660564Wetzel O, Schmidt AR, Seiler M, Scaramuzza D, Seifert B, Spahn DR, Stein P. A smartphone application to determine body length for body weight estimation in children: a prospective clinical trial. J Clin Monit Comput. 2018 Jun;32(3):571-578. doi: 10.1007/s10877-017-0041-z. Epub 2017 Jun 28.
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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.
Donat R Spahn, M.D., F.R.C.A. study chair
University and Universtity Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Size Measurement by a Smart phone App in people with Growth and Development, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 2 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 3 May 2017. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the size measured by the smart phone app with the child's size. (time frame: immediate, no follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805192, which also lists 1 linked publication.
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 3 May 2017.