Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT04303494
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2020-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Heart Rate Variability on Cardiorespiratory Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014611', 'term': 'Vaccination'}], 'ancestors': [{'id': 'D016233', 'term': 'Immunotherapy, Active'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in AOP', 'timeFrame': 'record the sum of AOP events from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation', 'description': 'Difference in AOP events within 24 hours after - 24 hours before immunisation'}], 'secondaryOutcomes': [{'measure': 'Difference in prolonged hypoxaemic episodes', 'timeFrame': 'record SpO2 from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation', 'description': 'Difference in prolonged hypoxaemic episodes (SpO2 \\< 80% for at least 1 min) within 24 hours after - 24 hours before immunisation (CAP-trial definition).'}, {'measure': 'Difference in number of manual stimulations', 'timeFrame': 'number of manual stimulations within 24 hours after - 24 hours before immunisation', 'description': 'Difference in number of manual stimulations within 24 hours after - 24 hours before immunisation'}, {'measure': 'Difference in number increases in oxygen concentration', 'timeFrame': 'record oxygen concentration from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation', 'description': 'Difference in number increases in oxygen concentration within 24 hours after - 24 hours before immunisation'}, {'measure': 'Difference in number of increases in continuous positive airway pressure (CPAP)', 'timeFrame': 'within 24 hours after - 24 hours before immunisation', 'description': 'Difference in number of increases in continuous positive airway pressure (CPAP) within 24 hours after - 24 hours before immunisation'}, {'measure': 'Difference in number of reinstallations in continuous positive airway pressure (CPAP)', 'timeFrame': 'within 24 hours after - 24 hours before immunisation', 'description': 'Difference in number of reinstallations in continuous positive airway pressure (CPAP) within 24 hours after - 24 hours before immunisation'}, {'measure': 'Difference in number of endotracheal intubation', 'timeFrame': 'within 24 hours after - 24 hours before immunisation', 'description': 'Difference in number of endotracheal intubation for AOP events within 24 hours after - 24 hours before immunisation'}, {'measure': 'Difference in sample entropy (SampEn) of interbeat interval of heart rate (IBI)', 'timeFrame': '24 hours after - immediately prior to immunisation', 'description': 'Difference in SampEn of IBI 24 hours after - immediately prior to immunisation'}, {'measure': 'Difference in SampEn of IBI', 'timeFrame': 'preterm infants measured at 37 to 42 weeks', 'description': 'Difference in SampEn of IBI in preterm infants measured at 37 to 42 weeks postconceptional age vs. SampEn of IBI in term healthy control infants'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)']}, 'referencesModule': {'references': [{'pmid': '39805735', 'type': 'DERIVED', 'citation': 'Kaempfen S, Hug M, Sanchez C, Delgado-Eckert E, Schulzke SM. Heart Rate Variability Does Not Predict Recurrence of Apnoea of Prematurity After Ceasing Caffeine Therapy: A Prospective Cohort Study. Acta Paediatr. 2025 Jun;114(6):1371-1378. doi: 10.1111/apa.17579. Epub 2025 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study are to investigate whether heart rate variability (HRV) parameters derived from nonlinear time series analysis at five different time points have prognostic utility for assessing the risk of postimmunisation AOP in very preterm/very low birth weight infants immunised in the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '3 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'preterm infants and healthy control infants', 'eligibilityCriteria': "Inclusion criteria for preterm infants:\n\n* Gestational Age (GA) 22+0 to 31+6 weeks and/or birth weight 400 g to 1500 g\n* Chronological age \\> 7 days\n* Written informed parental consent\n\nInclusion criteria for term healthy control infants:\n\n* GA 37 to 42 weeks, chronological age 3 to 28 days (beyond initial transition after birth)\n* Hospitalised in the neonatal rooming-in unit of the University Children's Hospital Basel as healthy co-twin or healthy sibling, or neonate ready to be discharged home after reconvalescence from minor illness such as hyperbilirubinaemia\n* Written informed parental consent\n\nExclusion Criteria:\n\n* Major congenital malformations including neuromuscular disorders, thoracic malformations, major cardiac malformation\n* Lack of written informed parental consent"}, 'identificationModule': {'nctId': 'NCT04303494', 'briefTitle': 'Predictive Value of Heart Rate Variability on Cardiorespiratory Events', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Predictive Value of Heart Rate Variability on Cardiorespiratory Events of Preterm Infants Routinely Immunised in the Hospital', 'orgStudyIdInfo': {'id': '2018-01207; ks17Schulzke'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental1', 'description': 'preterm infants will be routinely immunised during primary hospitalisation', 'interventionNames': ['Biological: immunisation']}, {'label': 'Experimental2', 'description': 'preterm infants discharged and readmitted for immunisation during the 3-year period', 'interventionNames': ['Biological: immunisation']}, {'label': 'Control', 'description': 'healthy control infants', 'interventionNames': ['Biological: immunisation']}], 'interventions': [{'name': 'immunisation', 'type': 'BIOLOGICAL', 'description': 'combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination', 'armGroupLabels': ['Control', 'Experimental1', 'Experimental2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'country': 'Switzerland', 'facility': "University Children's Hospital Basel UKBB, University of Basel", 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Sven Schulzke, Prof. Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital Basel, UKBB"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}