Clinical trial NCT04869176: Effect of Caffeine on Heart Rate Variability in Newborns
Official title: Effect of Caffeine for Apnoea Treatment on Heart Rate Variability in Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Heart Rate Variability
Apnoea of Newborn
Newborn
Keywords: newborn
heart rate variability
caffeine
bed tilt
autonomic nervous system
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 25
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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parameters of HRV in two situations: while the treatment with caffeine citrate was ongoing and after the treatment was withdrawn.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

Eligibility criteria: 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

Primary outcomes:
measure: Association between caffeine treatment and total power (TP) spectrum of HRV
timeFrame: During Procedure
measure: Association between caffeine treatment and high frequency (HF) spectrum of HRV
timeFrame: During Procedure
measure: Association between caffeine treatment and low frequency (LF) spectrum of HRV
timeFrame: During Procedure
Secondary outcomes:
measure: The correlation between postmenstrual age and total power (TP) spectrum of HRV
timeFrame: During Procedure
measure: The correlation between postmenstrual age and high frequency (HF) spectrum of HRV
timeFrame: During Procedure
measure: The correlation between postmenstrual age and low frequency (LF) spectrum of HRV
timeFrame: During Procedure
measure: The effect of caffeine on heart rate
timeFrame: During Procedure
measure: The effect of caffeine on breathing frequency
timeFrame: During Procedure
measure: The effect of caffeine on arterial oxygen saturation
timeFrame: During Procedure
measure: The effect of caffeine on body temperature
timeFrame: During Procedure
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Petja Fister, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: