Predictive Value of Heart Rate Variability on Cardiorespiratory Events of Preterm Infants Routinely Immunised in the Hospital

University Hospital, Basel, Switzerland1 site in 1 country292 target enrollmentJuly 1, 2018

ConditionsPost-immunisation Apnoea and Bradycardia of Prematurity (AOP)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)
Sponsor: University Hospital, Basel, Switzerland
Enrollment: 292
Locations: 1
Primary Endpoint: Changes in AOP
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study are to investigate whether heart rate variability (HRV) parameters derived from nonlinear time series analysis at five different time points have prognostic utility for assessing the risk of postimmunisation AOP in very preterm/very low birth weight infants immunised in the hospital.

Registry

clinicaltrials.gov

Start Date

July 1, 2018

End Date

November 5, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Basel, Switzerland

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Major congenital malformations including neuromuscular disorders, thoracic malformations, major cardiac malformation
•Lack of written informed parental consent

Outcomes

Primary Outcomes

Changes in AOP

Time Frame: record the sum of AOP events from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation

Difference in AOP events within 24 hours after - 24 hours before immunisation

Secondary Outcomes

Difference in number of manual stimulations(number of manual stimulations within 24 hours after - 24 hours before immunisation)
Difference in number increases in oxygen concentration(record oxygen concentration from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation)
Difference in number of increases in continuous positive airway pressure (CPAP)(within 24 hours after - 24 hours before immunisation)
Difference in sample entropy (SampEn) of interbeat interval of heart rate (IBI)(24 hours after - immediately prior to immunisation)
Difference in number of endotracheal intubation(within 24 hours after - 24 hours before immunisation)
Difference in number of reinstallations in continuous positive airway pressure (CPAP)(within 24 hours after - 24 hours before immunisation)
Difference in prolonged hypoxaemic episodes(record SpO2 from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation)
Difference in SampEn of IBI(preterm infants measured at 37 to 42 weeks)