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Completed

NCT Number: NCT04869176

Effect of Caffeine 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.

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Key information

Conditions

Caffeine Apnoea of Newborn Heart Rate Variability Newborn

Age range

Up to 4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, Slovenia

About this study

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parameters of HRV in two situations: while the treatment with caffeine citrate was ongoing and after the treatment was withdrawn.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newborns with apnoea treated with caffeine citrate
  • newborns whose parents have signed the informed consent form

Exclusion criteria

  • severe perinatal hypoxia
  • infection
  • liver or renal insufficiency
  • neurological disorders
  • congenital anomalies

Treatment and study plan

Electrocardiogram

Diagnostic Test

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.

Other names: Holter ECG

Monitoring of vital functions

Diagnostic Test

Measuring of heart rate, breathing frequency, arterial oxygen saturation and body temperature while recording ECG.

Caffeine Citrate 5 mg/kg

Drug

Caffeine in the form of suspension was given to the newborns.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. The correlation between postmenstrual age 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 correlation between HRV parameters and postmenstrual age was tested with the Pearson correlation coefficient.

  2. The correlation between postmenstrual age 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 correlation between HRV parameters and postmenstrual age was tested with the Pearson correlation coefficient.

  3. The correlation between postmenstrual age 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 correlation between HRV parameters and postmenstrual age was tested with the Pearson correlation coefficient.

  4. The effect of caffeine on heart rate

    Time frame: 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.

  5. The effect of caffeine on breathing frequency

    Time frame: 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.

  6. The effect of caffeine on arterial oxygen saturation

    Time frame: 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.

  7. The effect of caffeine on body temperature

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Registry information

Official study title

Effect of Caffeine for Apnoea Treatment on Heart Rate Variability in Newborns

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 3, 2021
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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