Predictive Value of Heart Rate Variability on Cardiorespiratory Events

Completed

• Conditions: Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)
• Interventions: Biological: immunisation

• Registration Number: NCT04303494
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-11
• Primary Completion: 2022-11-05
• Study Completion: 2022-11-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental2	immunisation	preterm infants discharged and readmitted for immunisation during the 3-year period
Control	immunisation	healthy control infants
Experimental1	immunisation	preterm infants will be routinely immunised during primary hospitalisation

Primary Outcome Measures

Name	Time	Method
Changes in AOP	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 Outcome Measures

Name	Time	Method
Difference in number of manual stimulations	number of manual stimulations within 24 hours after - 24 hours before immunisation	Difference in 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 increases in oxygen concentration 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 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 SampEn of 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 endotracheal intubation for AOP events 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 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 prolonged hypoxaemic episodes (SpO2 \< 80% for at least 1 min) within 24 hours after - 24 hours before immunisation (CAP-trial definition).
Difference in SampEn of IBI	preterm infants measured at 37 to 42 weeks	Difference in SampEn of IBI in preterm infants measured at 37 to 42 weeks postconceptional age vs. SampEn of IBI in term healthy control infants

Trial Locations

Locations (1)

University Children's Hospital Basel UKBB, University of Basel; 🇨🇭 Basel, Switzerland