Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:45 AM
Study NCT ID:
NCT07401420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Life Sustaining Treatments in Critically Ill Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-01-27', 'size': 155594, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-06T04:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Physicians' attitudes and challenges regarding treatment withdrawal.", 'timeFrame': 'Interviews will be about 60 minutes', 'description': 'Observational qualitative study with semi-structured interviewsanalysed with thematic analyses'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical illness', 'Ethics', 'End of life care'], 'conditions': ['Critical Illness', 'Ethics', 'End of Life Care']}, 'referencesModule': {'references': [{'pmid': '38117514', 'type': 'BACKGROUND', 'citation': 'Malhotra AK, Shakil H, Smith CW, Sader N, Ladha K, Wijeysundera DN, Singhal A, Kulkarni AV, Wilson JR, Witiw CD, Nathens AB. Withdrawal of Life-Sustaining Treatment for Pediatric Patients With Severe Traumatic Brain Injury. JAMA Surg. 2024 Mar 1;159(3):287-296. doi: 10.1001/jamasurg.2023.6531.'}, {'pmid': '37773128', 'type': 'BACKGROUND', 'citation': "Zhong Y, Cavolo A, Labarque V, Gastmans C. Physicians' attitudes and experiences about withholding/withdrawing life-sustaining treatments in pediatrics: a systematic review of quantitative evidence. BMC Palliat Care. 2023 Sep 29;22(1):145. doi: 10.1186/s12904-023-01260-y."}, {'pmid': '35751075', 'type': 'BACKGROUND', 'citation': 'Zhong Y, Cavolo A, Labarque V, Gastmans C. Physician decision-making process about withholding/withdrawing life-sustaining treatments in paediatric patients: a systematic review of qualitative evidence. BMC Palliat Care. 2022 Jun 24;21(1):113. doi: 10.1186/s12904-022-01003-5.'}], 'seeAlsoLinks': [{'url': 'https://portal.icuregswe.org/utdata/2013-2023', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Summary of the Research on Withdrawing and Withholding Life-Sustaining Treatment for Critically Ill Children Background Medical treatments require regular evaluation to ensure they align with the patient's best interests, particularly in intensive care where quality of life is often compromised. In the context of critically ill children, the challenge increases as patients may not be fully conscious or capable of expressing their needs and preferences. While intensive care can extend life, end-of-life situations necessitate careful consideration to avoid providing futile treatments that do not benefit the patient.\n\nDecision-Making Complexity Identifying when further treatment is beneficial poses significant challenges, influenced by various factors including the wishes of the patient and guardians. Previous studies indicate variability among healthcare providers in treatment decisions, often stemming from personal experiences and emotional responses. However, comparable research focusing on critically ill children in Nordic contexts remains scarce. Medical decisions often require balancing potential benefits against the risks of extended suffering or loss of valuable time at the end of life.\n\nA previous survey on end-of-life care in Europe indicated similar attitudes across regions but highlighted the need for cultural considerations. Sweden's distinct social and cultural values, characterized by individualism and secularism, may influence practices surrounding life-sustaining treatment.\n\nResearch Aims This research aims to investigate the factors affecting decision-making regarding the withdrawal and withholding of life-sustaining treatments for critically ill children in Swedish and Nordic intensive care units (ICUs). It will examine practitioners' experiences, attitudes, and the relative impact of children's autonomy in these decisions, excluding neonatal care.\n\nKey scientific questions focus on Physicians' attitudes and challenges regarding treatment withdrawal.\n\nMethodology\n\nSemi-structured interviews in multiple ICUs to explore ethical dilemmas faced by physicians.", 'detailedDescription': "Summary of the Research on Withdrawing and Withholding Life-Sustaining Treatment for Critically Ill Children Background Medical treatments require regular evaluation to ensure they align with the patient's best interests, particularly in intensive care where quality of life is often compromised. In the context of critically ill children, the challenge increases as patients may not be fully conscious or capable of expressing their needs and preferences. While intensive care can extend life, end-of-life situations necessitate careful consideration to avoid providing futile treatments that do not benefit the patient.\n\nDecision-Making Complexity Identifying when further treatment is beneficial poses significant challenges, influenced by various factors including the wishes of the patient and guardians. Previous studies indicate variability among healthcare providers in treatment decisions, often stemming from personal experiences and emotional responses. However, comparable research focusing on critically ill children in Nordic contexts remains scarce. Medical decisions often require balancing potential benefits against the risks of extended suffering or loss of valuable time at the end of life.\n\nA previous survey on end-of-life care in Europe indicated similar attitudes across regions but highlighted the need for cultural considerations. Sweden's distinct social and cultural values, characterized by individualism and secularism, may influence practices surrounding life-sustaining treatment.\n\nResearch Aims This research aims to investigate the factors affecting decision-making regarding the withdrawal and withholding of life-sustaining treatments for critically ill children in Swedish and Nordic intensive care units (ICUs). It will examine practitioners' experiences, attitudes, and the relative impact of children's autonomy in these decisions, excluding neonatal care.\n\nKey scientific questions focus on Physicians' attitudes and challenges regarding treatment withdrawal.\n\nMethodology\n\nSemi-structured interviews in multiple ICUs to explore ethical dilemmas faced by physicians.The research question will be investigated through semi-structured individual interviews with physicians who work with children in intensive care units. This will include both intensive care specialists and physicians from other specialties, primarily pediatricians. Recruitment will involve contacting the four children's departments in Sweden to seek voluntary study participants. The children's clinics at the same hospitals will also be contacted to reach out to potential volunteers. Recruitment will thereafter proceed through repeated contact and snowballing, where interviewed participants will assist in the recruitment process.An interview guide will be created and piloted with three people for validation. Subsequently, the interview guide will be updated.\n\nThe interviews will be conducted via links and verbatim transcription with the help of speech recognition software, which will be connected to the interviewer during the interview. Analysis will occur in NVivo using Qualitative Content Analysis according to Granheim and Lundman, based on narrative theory."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\- Specialist physicians in critical care with experience from end of life care in critically ill children.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Specialist physicians in critical care with experience from end of life care in critically ill children.\n\nExclusion Criteria:\n\nNone\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07401420', 'acronym': 'LST-Ped-Int', 'briefTitle': 'Life Sustaining Treatments in Critically Ill Children', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': "Project Plan Physicians' Experiences of the Decision-making Process Regarding Decisions to Withhold/Discontinue Life-sustaining Treatment in Children Cared for in Intensive Care Units in Sweden. A Qualitative Study.", 'orgStudyIdInfo': {'id': 'LST-Ped-Int'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intensive care physicians', 'description': 'Intensive care physicians', 'interventionNames': ['Other: There is no intervention']}], 'interventions': [{'name': 'There is no intervention', 'type': 'OTHER', 'description': 'Observational study', 'armGroupLabels': ['Intensive care physicians']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Linda E Block, Associate professor', 'role': 'CONTACT', 'email': 'linda.block@gu.se', 'phone': '+46709955110'}]}, 'ipdSharingStatementModule': {'url': 'http://Datawillnotbesharedonawebsite', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Upon reasonable request', 'ipdSharing': 'YES', 'description': 'All IPD that cannot be traced to an individual person.', 'accessCriteria': 'Upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}