Trial · NCT04869176
Effect of Caffeine on Heart Rate Variability in Newborns
NCT04869176, Not applicable, Completed, University of Ljubljana
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Caffeine on Heart Rate Variability in Newborns. Trials, record NCT04869176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04869176
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Caffeine on Heart Rate Variability in Newborns
- NCT number
- NCT04869176
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 25 participants, actual
- Lead sponsor
- University of Ljubljana
- Conditions
- Caffeine, Heart Rate Variability, Apnoea of Newborn, Newborn
- Interventions
- Electrocardiogram, Monitoring of vital functions, Caffeine Citrate 5 mg/kg
- First posted
- 2021-05-03
- Last updated
- 2021-05-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Association between caffeine treatment and total power (TP) spectrum of HRV | 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. |
| Primary | Association between caffeine treatment and high frequency (HF) spectrum of HRV | 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. |
| Primary | Association between caffeine treatment and low frequency (LF) spectrum of HRV | 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. |
| Secondary | The correlation between postmenstrual age and total power (TP) spectrum of HRV | 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 correlation between HRV parameters and postmenstrual age was tested with the Pearson correlation coefficient. |
| Secondary | The correlation between postmenstrual age and high frequency (HF) spectrum of HRV | 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 correlation between HRV parameters and postmenstrual age was tested with the Pearson correlation coefficient. |
| Secondary | The correlation between postmenstrual age and low frequency (LF) spectrum of HRV | 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 correlation between HRV parameters and postmenstrual age was tested with the Pearson correlation coefficient. |
| Secondary | The effect of caffeine on heart rate | During Procedure | 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. |
| Secondary | The effect of caffeine on breathing frequency | During Procedure | 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. |
| Secondary | The effect of caffeine on arterial oxygen saturation | During Procedure | 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. |
| Secondary | The effect of caffeine on body temperature | During Procedure | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04869176
GET https://conductscience.org/api/trials/v1/NCT04869176/registered