Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-01-07 @ 7:10 AM
Study NCT ID:
NCT05312333
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2022-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-06-07', 'releaseDate': '2023-12-10'}], 'estimatedResultsFirstSubmitDate': '2023-12-10'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2022-03-13', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormalities detecred in Holter monitoring of critically-ill childern', 'timeFrame': 'one year', 'description': 'the relation between abnormalities detected in Holter and prognosis of critically-ill childern'}, {'measure': 'The relation between heart rate variability and outcome ,prognosis of illness', 'timeFrame': 'one year', 'description': 'Increased illness severity and poor outcomes ,the most common method of objectively assesing autonomic nervous system dysregulation is through measurement of heart rate variability ,which reflect the normal ,physiologic alternation in the intervals in the time between consecutive heart beats that occur when there is balance of sympathetic and parasympathetic inputs on the electrical conduction system of the heart.'}, {'measure': 'Arrhythmia detected in critically-ill childern', 'timeFrame': 'one year', 'description': 'arrhythmia detected in Holter of critically ill childern whom have any critical illness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically Ill Childern in PICU']}, 'referencesModule': {'references': [{'pmid': '16472287', 'type': 'BACKGROUND', 'citation': 'Kennedy HL. The history, science, and innovation of Holter technology. Ann Noninvasive Electrocardiol. 2006 Jan;11(1):85-94. doi: 10.1111/j.1542-474X.2006.00067.x.'}, {'pmid': '31100075', 'type': 'BACKGROUND', 'citation': 'Marsillio LE, Manghi T, Carroll MS, Balmert LC, Wainwright MS. Heart rate variability as a marker of recovery from critical illness in children. PLoS One. 2019 May 17;14(5):e0215930. doi: 10.1371/journal.pone.0215930. eCollection 2019.'}, {'pmid': '23685639', 'type': 'BACKGROUND', 'citation': "Leteurtre S, Duhamel A, Salleron J, Grandbastien B, Lacroix J, Leclerc F; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). PELOD-2: an update of the PEdiatric logistic organ dysfunction score. Crit Care Med. 2013 Jul;41(7):1761-73. doi: 10.1097/CCM.0b013e31828a2bbd."}, {'pmid': '11286528', 'type': 'BACKGROUND', 'citation': 'Rijnbeek PR, Witsenburg M, Schrama E, Hess J, Kors JA. New normal limits for the paediatric electrocardiogram. Eur Heart J. 2001 Apr;22(8):702-11. doi: 10.1053/euhj.2000.2399.'}]}, 'descriptionModule': {'briefSummary': 'Holter Monitoring is a way to continuously check the electrical activity of the heart .\n\nContinuous ECG recording show to be one of the most effective noninvasive clinical tools in the diagnosis of cardiac symptoms prognostic assessment and in the evaluation of many cardiac therapeutic intervention.\n\nThe clinical utility of ambulatory ECG lies in its ability to examine continuously a patient over an extended period of time, permitting patient ambulatory activity and facilitating the diurnal electrocardiographic examination of a patient in a changing environmental conditions (both physical and psychological) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill children are those children whom requiring, or potentially requiring, high reliance or serious consideration.\n\nThere are variant emergent conditions may affect the child, such as airway problems which includes tonsillitis, airway obstruction which caused be foreign-body, pneumonia, asthma, and bronchitis, in addition to cardiac arrest and respiratory failure. There is also abdominal pain diarrhea, nausea, and vomiting. Child also may face seizures, poisoning sudden infant death syndrome (SIDS).\n\n* Having seizures; unusual movements.\n* No spontaneous development, unfit to sit or stand.\n* Less alert or drew in with clinician or parental figure; not resisting of the examination.\n* No interaction or eye-to-eye connection with individuals and the surrounding.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1- children admitted to pediatric department as in :\n* Pediatric intensive care unit (PICU).\n* Pediatric critical care unit (PCCU).\n* Emergency room (ER). 2- Age from 1 month- 12 years. 3- Critical ill child fulfill these criteria:\n* Persistent convulsions.\n* Abnormal GCS\n* Haemodynamic instability\n* Foreign body inhalation\n* Sever cardiac problem\n* Irregular breathing\n* DKA\n* Others\n\nExclusion Criteria:1-Neonates 2-End-stage or those with end-organ failure . 3-Whom GCS is below 6. 4-Whom done cardiac catheterization for any purpose . 5-Previously done Holter. 6-Multiple traumatized patient.'}, 'identificationModule': {'nctId': 'NCT05312333', 'briefTitle': 'Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital', 'orgStudyIdInfo': {'id': 'Soh-Med-22-03-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'critically-ill childern'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Osama R ElSherif, professor', 'role': 'CONTACT', 'email': 'portal@med.sohag.edu.eg'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at pediateric department sohag university hospital', 'investigatorFullName': 'Nourhan Ahmed Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-10', 'type': 'RELEASE'}, {'date': '2024-06-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nourhan Ahmed Mohamed, resident doctor at pediateric department sohag university hospital, Sohag University'}}}}