Effect of Caffeine on Heart Rate Variability in Newborns
NCT ID: NCT04869176
Last Updated: 2021-05-03
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
NA
25 participants
INTERVENTIONAL
2017-11-17
2018-07-31
Brief Summary
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Detailed Description
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In this study, the investigators performed measurements on one sample of 25 newborns with apnoea who had been admitted to the Neonatal Department of University Medical Centre Ljubljana and treated with caffeine citrate. The treatment regimen consisted of caffeine citrate of a loading dose of 20 mg/kg of body mass, followed by a daily maintenance dose of 5 mg/kg after 24 hours. The investigators measured parameters of HRV in two situations: while the treatment with caffeine citrate was ongoing and after the treatment was withdrawn. The newborns served as controls. Electrical activity of the heart was measured with a Holter ECG while the newborn was sleeping in supine position, first without a bed tilt and afterwards with a 30° head-up tilt. Simultaneously was evaluated the alertness of the newborn and measured their physiological variables (the breathing frequency, the heart rate, the arterial oxygen saturation, and the body temperature).
All parents were given their written consent for their child to participate in the study.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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On Caffeine, maintenance dose
During receiving maintenance dose of 5 mg/kg caffeine citrate (i.e. 2,5 mg/kg caffeine) in the form of solution, orally or intravenously, Holter electrocardiogram and vital functions were monitored for 40 minutes.
Electrocardiogram
Recording of the electrical activity of the heart during sleep; sleep phases were evaluated. The bed was initially in horizontal position and tilted for 30° head-up after 20 minutes of continuous tracing.
Monitoring of vital functions
Measuring of heart rate, breathing frequency, arterial oxygen saturation and body temperature while recording ECG.
Caffeine Citrate 5 mg/kg
Caffeine in the form of suspension was given to the newborns.
Off caffeine
100 hours after caffeine withdrawal Holter electrocardiogram and vital functions were monitored for 40 minutes.
Electrocardiogram
Recording of the electrical activity of the heart during sleep; sleep phases were evaluated. The bed was initially in horizontal position and tilted for 30° head-up after 20 minutes of continuous tracing.
Monitoring of vital functions
Measuring of heart rate, breathing frequency, arterial oxygen saturation and body temperature while recording ECG.
Interventions
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Electrocardiogram
Recording of the electrical activity of the heart during sleep; sleep phases were evaluated. The bed was initially in horizontal position and tilted for 30° head-up after 20 minutes of continuous tracing.
Monitoring of vital functions
Measuring of heart rate, breathing frequency, arterial oxygen saturation and body temperature while recording ECG.
Caffeine Citrate 5 mg/kg
Caffeine in the form of suspension was given to the newborns.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* newborns whose parents have signed the informed consent form
Exclusion Criteria
* infection
* liver or renal insufficiency
* neurological disorders
* congenital anomalies
4 Weeks
ALL
No
Sponsors
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University of Ljubljana
OTHER
Responsible Party
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Petja Fister
Assist. Prof. Petja Fister, MD, PhD
Principal Investigators
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Petja Fister, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Centre Ljubljana
Locations
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University Medical Centre Ljubljana
Ljubljana, , Slovenia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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0120-458/2016-3
Identifier Type: -
Identifier Source: org_study_id
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