Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-03-02 @ 8:39 PM
Study NCT ID:
NCT02640703
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2015-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022681', 'term': 'Diphtheria-Tetanus-acellular Pertussis Vaccines'}, {'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}], 'ancestors': [{'id': 'D010567', 'term': 'Pertussis Vaccine'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004168', 'term': 'Diphtheria Toxoid'}, {'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D022282', 'term': 'Vaccines, Acellular'}, {'id': 'D022223', 'term': 'Vaccines, Subunit'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2015-12-12', 'studyFirstSubmitQcDate': '2015-12-22', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hypoxia and bradycardia events', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Vaccination titer in blood sample after vaccination compared to vaccination titer in blood sample before vaccination', 'timeFrame': 'Before vaccination and at the age of 4 months (corrected age)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Premature Birth', 'Intermittent Hypoxiema']}, 'descriptionModule': {'briefSummary': 'Hypoxia/bradycardia are common symptoms after vaccination of preterm infants. Adults show diurnal variations in vaccination response, due to circadian regulation of the immune system. The investigators plan to investigate whether preterm infants also show differences in hypoxia/bradycardia rate upon morning vs. evening vaccination.\n\nHypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours after vaccination; parents also kept a sleep-diary. 24 hours after vaccination interleukin-6, interleukin-1β and C-reactive protein get determined. To control vaccination response, pertussis- and haemophilus-titers are determined before vaccination and at 4 months corrected age.', 'detailedDescription': 'Intervention: First hexavalent vaccination given to very preterm infants either in the evening or in the morning.\n\nPrimary outcome: rate of desaturations (SpO2 \\<80%) and bradycardias (Pulse rate \\<100/min) in first 24 h following vaccination in evening vs. morning vaccination group Secondary outcomes: cytokine levels (IL 6, IL 1ß, CRP) measured 24 h after vaccination, pertussis- and haemophilus-titers as measured before and after vaccination, i.e. at 4 months corrected age, in evening vs. morning vaccination group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '30 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational Age: 26+0 to 30+6 Weeks of gestational age\n\nExclusion Criteria:\n\n* bronchopulmonary dysplasia\n* periventricular leukomalacia\n* intraventricular hemorrhage \\>°2\n* congenital malformations'}, 'identificationModule': {'nctId': 'NCT02640703', 'briefTitle': 'Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial', 'orgStudyIdInfo': {'id': 'Impfstudie'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'morning vaccination', 'description': 'Vaccination with Infanrix + Prevenar 13 between 7 and 10 am', 'interventionNames': ['Biological: Infanrix + Prevenar 13']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'evening vaccination', 'description': 'Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm', 'interventionNames': ['Biological: Infanrix + Prevenar 13']}], 'interventions': [{'name': 'Infanrix + Prevenar 13', 'type': 'BIOLOGICAL', 'description': 'Different time of application', 'armGroupLabels': ['evening vaccination', 'morning vaccination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Childrens Hospital', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Christian F. Poets, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Neonatology, Tuebingen University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Christian F. Poets', 'investigatorFullName': 'Prof. Dr. Christian Poets', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}