Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-01-07 @ 4:02 AM
Study NCT ID:
NCT02805192
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2016-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Smart Phone App to Non-invasively Measure the Size of Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 627}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-30'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Comparison of the size measured by the smart phone app with the child's size.", 'timeFrame': 'immediate, no follow up'}], 'secondaryOutcomes': [{'measure': 'Comparison of the estimations calculated upon the smart phone measured size (via known percentiles) with the real age and weight.', 'timeFrame': 'immediate, no follow up'}, {'measure': 'Comparison of estimations by "Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®" with real age and weight.', 'timeFrame': 'immediate, no follow up'}, {'measure': 'Comparison of estimations by parents, physicians and nurses with the actual size and weight.', 'timeFrame': 'immediate, no follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Emergency Department', 'Estimation of age and weight', 'Size measurement'], 'conditions': ['Growth and Development']}, 'referencesModule': {'references': [{'pmid': '28660564', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nDepending 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.\n\nChildren 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male and female patients 0-12 years of age (45 per age group)\n* obtained informed consent\n* admitted to the emergency department of the Children's Hospital of the University of Zurich\n\nExclusion Criteria:\n\n* physically or mentally unable for measurement\n* denial of informed consent"}, 'identificationModule': {'nctId': 'NCT02805192', 'briefTitle': 'Validation of a Smart Phone App to Non-invasively Measure the Size of Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Validation of a Smart Phone App to Non-invasively Measure the Size of Children', 'orgStudyIdInfo': {'id': 'KEK 2016-271, 94-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'one Arm: size measurement by Smart phone App', 'interventionNames': ['Device: Size Measurement by a Smart phone App']}], 'interventions': [{'name': 'Size Measurement by a Smart phone App', 'type': 'DEVICE', 'armGroupLabels': ['one Arm: size measurement by Smart phone App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universtity Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Donat R Spahn, M.D., F.R.C.A.', 'role': 'STUDY_CHAIR', 'affiliation': 'University and Universtity Hospital Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Philipp Stein', 'investigatorFullName': 'Philipp Stein', 'investigatorAffiliation': 'University of Zurich'}}}}