Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-03-03 @ 9:28 PM
Study NCT ID:
NCT03105557
Status:
UNKNOWN
Last Update Posted:
2023-02-27
First Post:
2017-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rickets Device - Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012279', 'term': 'Rickets'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-24', 'studyFirstSubmitDate': '2017-03-03', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents', 'timeFrame': '1 day', 'description': 'With concern to feasibility we want to know whether this device is able:\n\n* easy to apply to the neonate\n* to only collect urine\n* to exclude stool admixture\n* easy to use by the nurses\n* comfortable for te neonates'}], 'secondaryOutcomes': [{'measure': 'Skin reactions', 'timeFrame': '1 week', 'description': 'Number of times skin reactions occurs, reported by the responsible nurse'}, {'measure': 'Skin irritability', 'timeFrame': '1 week', 'description': 'Number of times skin irritability occurs, reported by the responsible nurse'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prematurely born newborns', 'Urine', 'Collecting device'], 'conditions': ['Rickets']}, 'descriptionModule': {'briefSummary': 'On a daily basis many (prematurely born) newborn are subjected to different urine collecting techniques to study biochemical abnormalities. Neonatology nurses and pediatricians are looking for a better and less invasive manner to collect urine in these vulnerable patients. We hypothesise that the urine collecting device as presented in this protocol is less invasive and has good functional abilities to collect urine in these newborns\n\nObjective of the study:\n\nClinical feasibility of the urine collection device, indicated by staff and parents.\n\nStudy design:\n\nThe study will be an open label, clinical feasibility study, of the urine collection device. During a period of 6 months, 30 feasibility tests will be performed.\n\nStudy population:\n\nPrematurely born newborns, admitted to the neonatology unit of the department of pediatrics at Rijnstate Hospital Arnhem.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will consist of prematurely born neonates who are admitted to the neonatology unit. And for which the attending physician has an indication to screen for rickets using calcium,phosphate and creatinine level measurement in urine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates admitted to the neonatology unit of the paediatrics department of Rijnstate Hospital Medical indication for urine testing for Calcium, Phosphate and Creatinine levels Informed consent from parents\n\nExclusion Criteria:\n\n* No informed consent\n* Defective skin in genital region\n* Three previous tests in the same subject'}, 'identificationModule': {'nctId': 'NCT03105557', 'briefTitle': 'Rickets Device - Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Capturin Distribution B.V.'}, 'officialTitle': 'Rachitis Device Study', 'orgStudyIdInfo': {'id': 'NL55778.091.15'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Urinary collecting device', 'type': 'DEVICE', 'otherNames': ['Capturin'], 'description': 'Urinary collecting device'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6800 TA', 'city': 'Arnhem', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Petra Van Setten', 'role': 'CONTACT', 'email': 'petra.vansetten@radboudumc.nl', 'phone': '+31(0)880058888'}, {'name': 'Bianca Baten', 'role': 'CONTACT', 'email': 'bbaten@rijnstate.nl', 'phone': '+31(0)880056671'}], 'facility': 'Petra Van Setten', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'centralContacts': [{'name': 'Petra Van Setten', 'role': 'CONTACT', 'email': 'petra.vansetten@radboudumc.nl', 'phone': '+31 (0)24 361 1111'}, {'name': 'Bianca Baten', 'role': 'CONTACT', 'email': 'bbaten@rijnstate.nl', 'phone': '+31(0)880056671'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capturin Distribution B.V.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fonds NutsOhra', 'class': 'OTHER'}, {'name': 'FrieslandCampina', 'class': 'INDUSTRY'}, {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, {'name': 'Scint B.V.', 'class': 'UNKNOWN'}, {'name': 'Hertog Hendrik BV', 'class': 'UNKNOWN'}, {'name': 'University of Twente', 'class': 'OTHER'}, {'name': 'Radboud University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}