Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT01769118
Status:
COMPLETED
Last Update Posted:
2015-05-08
First Post:
2013-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Influences of Caffeine on Heart Rate Variability of Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-06', 'studyFirstSubmitDate': '2013-01-14', 'studyFirstSubmitQcDate': '2013-01-15', 'lastUpdatePostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': '1 hour', 'description': 'Heart rate, SD, SDNN, HF, LF, VLF, TP'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Autonomic nervous system'], 'conditions': ['Autonomic Nervous System']}, 'descriptionModule': {'briefSummary': 'Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm infant who get caffeine before stopping ventilation. The investigators hypothesis is that this stimulatory effect may be characterized by HRV analysis methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '25 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '25 preterm infants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants born before 34 weeks gestation\n\nExclusion Criteria:\n\n* sepsis\n* congenital malformations'}, 'identificationModule': {'nctId': 'NCT01769118', 'briefTitle': 'The Influences of Caffeine on Heart Rate Variability of Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Influences of Caffeine on HRV of Preterm Infants', 'orgStudyIdInfo': {'id': '0442-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caffeine', 'description': 'caffeine will be given according to clinical judgment', 'interventionNames': ['Drug: Caffeine']}], 'interventions': [{'name': 'Caffeine', 'type': 'DRUG', 'description': 'Caffeine will be given according to departmental protocol', 'armGroupLabels': ['Caffeine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'RMC', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'wamir', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}