Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-01-01 @ 7:30 PM
Study NCT ID:
NCT07070258
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2025-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Intensive Care Transport Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-07-08', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Most frequent reason for pediatric intensive care transport', 'timeFrame': 'At enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intensive care transport', 'critical care transport', 'pediatrics', 'registry'], 'conditions': ['Critical Care Medicine', 'Transportation of Patients', 'Pediatrics']}, 'descriptionModule': {'briefSummary': 'The aim is to establish a nationwide registry for pediatric intensive care transports in Germany. The project aims to describe and analyse the need for, and current practice of, specialised transports. These data could then be used for future demand planning.', 'detailedDescription': 'In contrast to critical care transport of adults or newborns, transport of pediatric critical care patients in Germany is neither regulated by law nor centrally organized. Due to their different therapeutic needs compared to newborns or adults, critically ill children may receive insufficient treatment during transport. In some regions in Germany, pediatric centers provide specialized pediatric retrieval teams, while others organize each transport individually. Currently, no valid data on pediatric critical care transports in Germany are available, nor are they recorded in a structured manner.\n\nA nationwide registry for pediatric intensive care transports in Germany was initiated to describe and analyze the need for and current practice of these specialized transports.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '27 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All critically ill children undergoing interhospital pediatric intensive care transport and arriving at a participating center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically ill children aged at least 27 days and a corrected gestational age of over 41 weeks AND\n* Maximum age of 17 years AND\n* Interhospital transport AND\n* Critical care transport by a dedicated critical care transport team using an intensive care ambulance (Type C vehicle) or an air ambulance OR\n* The transport was accompanied by a specialist in intensive care or emergency medicine. OR\n* The in-hospital destination of the transport is a critical care area, such as an intensive care unit, a trauma room, a resuscitation area, an operating theatre, an emergency imaging procedure or an emergency intervention.'}, 'identificationModule': {'nctId': 'NCT07070258', 'acronym': 'PIT Registry', 'briefTitle': 'Pediatric Intensive Care Transport Registry', 'organization': {'class': 'OTHER', 'fullName': 'Philipps University Marburg'}, 'officialTitle': 'Pediatric Intensive Care Transport Registry', 'orgStudyIdInfo': {'id': 'REG-EK-270072024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill children undergoing interhospital pediatric intensive care transport', 'description': 'All critically ill children undergoing interhospital pediatric intensive care transport, aged at least 27 days and with a corrected gestational age of over 41 weeks, are eligible for inclusion. The upper age limit for enrolment is 18 years. Critical care transports are defined as transports that meet at least one of the following criteria: I) The transport was performed by a dedicated critical care transport team using an intensive care ambulance (Type C vehicle) or an air ambulance. II) The transport was accompanied by a specialist in intensive care or emergency medicine. III) The in-hospital destination of the transport is a critical care area, such as an intensive care unit, a trauma room, a resuscitation area, an operating theatre, an emergency imaging procedure or an emergency intervention.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'University of Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '35043', 'city': 'Marburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Philipps University of Marburg', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}], 'centralContacts': [{'name': 'Nadine Mand, Dr. med.', 'role': 'CONTACT', 'email': 'mandn@staff.uni-marburg.de', 'phone': '004964215862671'}, {'name': 'Stefan Winkler, Dr. med.', 'role': 'CONTACT', 'email': 'stefan.winkler@uniklinikum-dresden.de', 'phone': '0049 351 458-18552'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philipps University Marburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Neonatology and Pediatric Intensive Care, Department of Pediatrics, Marburg', 'investigatorFullName': 'Dr. med. Nadine Mand', 'investigatorAffiliation': 'Philipps University Marburg'}}}}