Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
NCT ID: NCT02640703
Last Updated: 2017-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
16 participants
INTERVENTIONAL
2015-03-31
2017-05-31
Brief Summary
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Hypoxia/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.
Detailed Description
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Primary 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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morning vaccination
Vaccination with Infanrix + Prevenar 13 between 7 and 10 am
Infanrix + Prevenar 13
Different time of application
evening vaccination
Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm
Infanrix + Prevenar 13
Different time of application
Interventions
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Infanrix + Prevenar 13
Different time of application
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* periventricular leukomalacia
* intraventricular hemorrhage \>°2
* congenital malformations
30 Days
6 Months
ALL
Yes
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Prof. Dr. Christian Poets
Prof. Dr. med. Christian F. Poets
Principal Investigators
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Christian F. Poets, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dept. of Neonatology, Tuebingen University Hospital
Locations
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University Childrens Hospital
Tübingen, , Germany
Countries
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Other Identifiers
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Impfstudie
Identifier Type: -
Identifier Source: org_study_id