MedTrace Logo

Effect of Caffeine on Heart Rate Variability in Newborns

NCT04869176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-05-03

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Ljubljana

    lead OTHER

Principal Investigators

  • Petja Fister, MD, PhD · University Medical Centre Ljubljana

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-17
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Slovenia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04869176 on ClinicalTrials.gov