NCT04869176

Effect of Caffeine on Heart Rate Variability in Newborns

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Ljubljana · Academic / Other
• Sex: All
• Age: 4 Weeks
• Healthy volunteers: Not accepted

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parameters of HRV in two situations: while the treatment with caffeine citrate was ongoing and after the treatment was withdrawn.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

Conditions

• Caffeine
• Heart Rate Variability
• Apnoea of Newborn
• Newborn

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Electrocardiogram	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.
DIAGNOSTIC_TEST	Monitoring of vital functions	Measuring of heart rate, breathing frequency, arterial oxygen saturation and body temperature while recording ECG.
DRUG	Caffeine Citrate 5 mg/kg	Caffeine in the form of suspension was given to the newborns.

Timeline

• Start date: 2017-11-17
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2021-05-03
• Last updated: 2021-05-03

Locations

1 site across 1 country: Slovenia