Effect of Caffeine for Apnoea Treatment on Heart Rate Variability in Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Association between caffeine treatment and total power (TP) spectrum of HRV
研究概览
简要总结
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.
详细描述
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parameters of HRV in two situations: while the treatment with caffeine citrate was ongoing and after the treatment was withdrawn.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newborns with apnoea treated with caffeine citrate
- •newborns whose parents have signed the informed consent form
排除标准
- •severe perinatal hypoxia
- •infection
- •liver or renal insufficiency
- •neurological disorders
- •congenital anomalies
研究组 & 干预措施
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.
干预措施: Electrocardiogram (Diagnostic Test)
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.
干预措施: Monitoring of vital functions (Diagnostic Test)
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.
干预措施: Caffeine Citrate 5 mg/kg (Drug)
Off caffeine
100 hours after caffeine withdrawal Holter electrocardiogram and vital functions were monitored for 40 minutes.
干预措施: Electrocardiogram (Diagnostic Test)
Off caffeine
100 hours after caffeine withdrawal Holter electrocardiogram and vital functions were monitored for 40 minutes.
干预措施: Monitoring of vital functions (Diagnostic Test)
结局指标
主要结局
Association between caffeine treatment and total power (TP) spectrum of HRV
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- The correlation between postmenstrual age and low frequency (LF) spectrum of HRV(During Procedure)
- The effect of caffeine on arterial oxygen saturation(During Procedure)
- The correlation between postmenstrual age and total power (TP) spectrum of HRV(During Procedure)
- The correlation between postmenstrual age and high frequency (HF) spectrum of HRV(During Procedure)
- The effect of caffeine on heart rate(During Procedure)
- The effect of caffeine on breathing frequency(During Procedure)
- The effect of caffeine on body temperature(During Procedure)
研究者
Petja Fister
Assist. Prof. Petja Fister, MD, PhD
University of Ljubljana