Effect of Caffeine on Heart Rate Variability in Newborns

University of Ljubljana

Status: Completed

Conditions: Caffeine; Apnoea of Newborn; Newborn; Heart Rate Variability

Treatments: Diagnostic Test: Monitoring of vital functions; Drug: Caffeine Citrate 5 mg/kg; Diagnostic Test: Electrocardiogram

Study type: Interventional

Funder types: Other

Identifiers

NCT04869176

0120-458/2016-3

Details and patient eligibility

About

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.

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parameters of HRV in two situations: while the treatment with caffeine citrate was ongoing and after the treatment was withdrawn.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

Enrollment: 25 patients

Sex: All

Ages: Under 4 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

On Caffeine, maintenance dose

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Electrocardiogram

Drug: Caffeine Citrate 5 mg/kg

Diagnostic Test: Monitoring of vital functions

Off caffeine

Experimental group

Description:

100 hours after caffeine withdrawal Holter electrocardiogram and vital functions were monitored for 40 minutes.

Treatment:

Diagnostic Test: Electrocardiogram

Diagnostic Test: Monitoring of vital functions