CaffeineNCT04869176
Effect of Caffeine on Heart Rate Variability in Newborns
A study testing Electrocardiogram, Monitoring of vital functions and Caffeine Citrate 5 mg/kg in people with Caffeine and Heart Rate Variability, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
The aim of this study was to evaluate the impact of caffeine treatment, given either orally or intravenously, on heart rate variability in newborns. In addition, the investigators sought for a potential association between caffeine treatment and vital functions. Read more about this study
- Who is it for?
- Ages Up to 4 weeks
- Conditions the study is for
- Caffeine, Heart Rate Variability, Apnoea of Newborn
- What is being tested?
- Electrocardiogram, Monitoring of vital functions and Caffeine Citrate 5 mg/kg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSlovenia
- Study dates
- 17 Nov 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- newborns with apnoea treated with caffeine citrate
- newborns whose parents have signed the informed consent form
Who cannot join
- severe perinatal hypoxia
- infection
- liver or renal insufficiency
- neurological disorders
- congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Caffeine for Apnoea Treatment on Heart Rate Variability in Newborns
The aim of this study was to evaluate the impact of caffeine treatment, given either orally or intravenously, on heart rate variability in newborns. In addition, the investigators sought for a potential association between caffeine treatment and vital functions.
Read the detailed description
At Neonatal Department of University Medical Centre Ljubljana caffeine is used to treat neonatal apnoea. It has known affects on central nervous and cardiovascular systems, but little is known about the impact of caffeine intake on heart rate variability (HRV) in newborns.
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
- Caffeine, Heart Rate Variability, Apnoea of Newborn, Newborn
- Being tested
- Electrocardiogram, Monitoring of vital functions, Caffeine Citrate 5 mg/kg
- Keywords
- newborn, heart rate variability, caffeine, bed tilt, autonomic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramDiagnostic test
Also called Holter ECG
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 functionsDiagnostic test
Measuring of heart rate, breathing frequency, arterial oxygen saturation and body temperature while recording ECG.
Caffeine Citrate 5 mg/kgDrug
Caffeine in the form of suspension was given to the newborns.
| Study group | Role | What they receive |
|---|---|---|
| On Caffeine, maintenance dose | Experimental | 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. Receives: Diagnostic Test: Electrocardiogram; Diagnostic Test: Monitoring of vital functions; Drug: Caffeine Citrate 5 mg/kg |
| Off caffeine | Experimental | 100 hours after caffeine withdrawal Holter electrocardiogram and vital functions were monitored for 40 minutes. Receives: Diagnostic Test: Electrocardiogram; Diagnostic Test: Monitoring of vital functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between caffeine treatment and total power (TP) spectrum of HRV
While the newborn was sleeping, the electrical activity of the heart was recorded by using ECG Holter. TP (ms2) was obtained from a suitable 5-minute ECG segment analysed by fast Fourier transform, using the Vision Premier Programme for each bed tilt. The values were compared across the two arms of the study, using student's t-test for comparisons of normally distributed variables, and Wilcoxon signed-rank test for abnormally distributed data.
Measured: During Procedure
Association between caffeine treatment and high frequency (HF) spectrum of HRV
While the newborn was sleeping, the electrical activity of the heart was recorded by using ECG Holter. HF (ms2) was obtained from a suitable 5-minute ECG segment analysed by fast Fourier transform, using the Vision Premier Programme for each bed tilt. The values were compared across the two arms of the study, using student's t-test for comparisons of normally distributed variables, and Wilcoxon signed-rank test for abnormally distributed data.
Measured: During Procedure
Association between caffeine treatment and low frequency (LF) spectrum of HRV
While the newborn was sleeping, the electrical activity of the heart was recorded by using ECG Holter. LF (ms2) was obtained from a suitable 5-minute ECG segment analysed by fast Fourier transform, using the Vision Premier Programme for each bed tilt. The values were compared across the two arms of the study, using student's t-test for comparisons of normally distributed variables, and Wilcoxon signed-rank test for abnormally distributed data.
Measured: During Procedure
Secondary outcomes (7)
The correlation between postmenstrual age and total power (TP) spectrum of HRV
While the newborn was sleeping, the electrical activity of the heart was recorded by using ECG Holter. TP (ms2) was obtained from a suitable 5-minute ECG segment analysed by fast Fourier transform, using the Vision Premier Programme for each bed tilt. The correlation between HRV parameters and postmenstrual age was tested with the Pearson correlation coefficient.
Measured: During Procedure
The correlation between postmenstrual age and high frequency (HF) spectrum of HRV
While the newborn was sleeping, the electrical activity of the heart was recorded by using ECG Holter. HF (ms2) was obtained from a suitable 5-minute ECG segment analysed by fast Fourier transform, using the Vision Premier Programme for each bed tilt. The correlation between HRV parameters and postmenstrual age was tested with the Pearson correlation coefficient.
Measured: During Procedure
The correlation between postmenstrual age and low frequency (LF) spectrum of HRV
While the newborn was sleeping, the electrical activity of the heart was recorded by using ECG Holter. LF (ms2) was obtained from a suitable 5-minute ECG segment analysed by fast Fourier transform, using the Vision Premier Programme for each bed tilt. The correlation between HRV parameters and postmenstrual age was tested with the Pearson correlation coefficient.
Measured: During Procedure
The effect of caffeine on heart rate
Heart rate (beats per minute) was obtained from the segments, recorded by ECG Holter and analysed by the Vision Premier Programme. The selected segments corresponded to the segments HRV parameters were obtained for each bed tilt. The values were compared across the two arms of the study.
Measured: During Procedure
The effect of caffeine on breathing frequency
Breathing frequency (breaths per minute) was determined manually by observing the chest movement. The measurement was performed three times while the newborn was sleeping for each bed tilt. The values were compared across the two arms of the study.
Measured: During Procedure
The effect of caffeine on arterial oxygen saturation
Arterial oxygen saturation (percent) was performed by a pulse oximeter attached to the right hand. The arterial oxygen saturation value was noted three times with the corresponding breathing frequency while the newborn was sleeping for each bed tilt. The values were compared across the two arms of the study.
Measured: During Procedure
The effect of caffeine on body temperature
Body temperature (degree Celsius) was measured by a frontal non-contact infrared thermometer three times for each bed tilt while the newborn was sleeping. The values were compared across the two arms of the study.
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start17 Nov 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petja Fister, University of Ljubljana
- Investigators
- Petja Fister, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869176
- Sponsor's protocol ID
- 0120-458/2016-3
- Status last verified
- Apr 2021
- First submitted
- 20 Mar 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Caffeine for Apnoea Treatment on Heart Rate Variability in Newborns
- ClinicalTrials.gov ID
- NCT04869176
- Acronym / sponsor ID
- 0120-458/2016-3
- Conditions
- Caffeine, Heart Rate Variability, Apnoea of Newborn, Newborn
- Keywords
- newborn, heart rate variability, caffeine, bed tilt, autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the impact of caffeine treatment, given either orally or intravenously, on heart rate variability in newborns. In addition, the investigators sought for a potential association between caffeine treatment and vital functions.
Detailed description
At Neonatal Department of University Medical Centre Ljubljana caffeine is used to treat neonatal apnoea. It has known affects on central nervous and cardiovascular systems, but little is known about the impact of caffeine intake on heart rate variability (HRV) in newborns.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On Caffeine, maintenance dose | Experimental | Diagnostic Test: Electrocardiogram, Diagnostic Test: Monitoring of vital functions, Drug: Caffeine Citrate 5 mg/kgDuring 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. |
| Off caffeine | Experimental | Diagnostic Test: Electrocardiogram, Diagnostic Test: Monitoring of vital functions100 hours after caffeine withdrawal Holter electrocardiogram and vital functions were monitored for 40 minutes. |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- newborns with apnoea treated with caffeine citrate
- newborns whose parents have signed the informed consent form
Key exclusion criteria (5 listed)
- severe perinatal hypoxia
- infection
- liver or renal insufficiency
- neurological disorders
- congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrocardiogramAlso: Holter ECGRecording 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. | Diagnostic test | Off caffeine, On Caffeine, maintenance dose |
| Monitoring of vital functionsMeasuring of heart rate, breathing frequency, arterial oxygen saturation and body temperature while recording ECG. | Diagnostic test | Off caffeine, On Caffeine, maintenance dose |
| Caffeine Citrate 5 mg/kgCaffeine in the form of suspension was given to the newborns. | Drug | On Caffeine, maintenance dose |
Primary outcome
Association between caffeine treatment and total power (TP) spectrum of HRV
Time frame: During Procedure
While the newborn was sleeping, the electrical activity of the heart was recorded by using ECG Holter. TP (ms2) was obtained from a suitable 5-minute ECG segment analysed by fast Fourier transform, using the Vision Premier Programme for each bed tilt. The values were compared across the two arms of the study, using student's t-test for comparisons of normally distributed variables, and Wilcoxon signed-rank test for abnormally distributed data.
Association between caffeine treatment and high frequency (HF) spectrum of HRV
Time frame: During Procedure
While the newborn was sleeping, the electrical activity of the heart was recorded by using ECG Holter. HF (ms2) was obtained from a suitable 5-minute ECG segment analysed by fast Fourier transform, using the Vision Premier Programme for each bed tilt. The values were compared across the two arms of the study, using student's t-test for comparisons of normally distributed variables, and Wilcoxon signed-rank test for abnormally distributed data.
Association between caffeine treatment and low frequency (LF) spectrum of HRV
Time frame: During Procedure
While the newborn was sleeping, the electrical activity of the heart was recorded by using ECG Holter. LF (ms2) was obtained from a suitable 5-minute ECG segment analysed by fast Fourier transform, using the Vision Premier Programme for each bed tilt. The values were compared across the two arms of the study, using student's t-test for comparisons of normally distributed variables, and Wilcoxon signed-rank test for abnormally distributed data.
7 secondary outcomes
The correlation between postmenstrual age and total power (TP) spectrum of HRV
Time frame: During Procedure
The correlation between postmenstrual age and high frequency (HF) spectrum of HRV
Time frame: During Procedure
The correlation between postmenstrual age and low frequency (LF) spectrum of HRV
Time frame: During Procedure
The effect of caffeine on heart rate
Time frame: During Procedure
The effect of caffeine on breathing frequency
Time frame: During Procedure
The effect of caffeine on arterial oxygen saturation
Time frame: During Procedure
The effect of caffeine on body temperature
Time frame: During Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petja Fister, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocardiogram, Monitoring of vital functions and Caffeine Citrate 5 mg/kg in people with Caffeine and Heart Rate Variability, run by University of Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between caffeine treatment and total power (TP) spectrum of HRV (time frame: During Procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.