Predictive Value of Heart Rate Variability on Cardiorespiratory Events

University Hospital, Basel, Switzerland292 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

292

Conditions

Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)

Interventions

immunisationBIOLOGICAL

combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination

Eligibility

Sex: ALLMin age: 3 DaysMax age: 28 Days

Medical Language ↔ Plain English

Inclusion criteria for preterm infants: * Gestational Age (GA) 22+0 to 31+6 weeks and/or birth weight 400 g to 1500 g * Chronological age \> 7 days * Written informed parental consent Inclusion criteria for term healthy control infants: * GA 37 to 42 weeks, chronological age 3 to 28 days (beyond initial transition after birth) * Hospitalised in the neonatal rooming-in unit of the University Children's Hospital Basel as healthy co-twin or healthy sibling, or neonate ready to be discharged home after reconvalescence from minor illness such as hyperbilirubinaemia * Written informed parental consent Exclusion Criteria: * Major congenital malformations including neuromuscular disorders, thoracic malformations, major cardiac malformation * Lack of written informed parental consent

Locations (1)

University Children's Hospital Basel UKBB, University of Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Changes in AOP

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

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

Secondary Outcomes

Difference in prolonged hypoxaemic episodes

Difference in prolonged hypoxaemic episodes (SpO2 \< 80% for at least 1 min) within 24 hours after - 24 hours before immunisation (CAP-trial definition).

Time frame: record SpO2 from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation

Difference in number of manual stimulations

Difference in number of manual stimulations within 24 hours after - 24 hours before immunisation

Time frame: number of manual stimulations within 24 hours after - 24 hours before immunisation

Difference in number increases in oxygen concentration

Difference in number increases in oxygen concentration within 24 hours after - 24 hours before immunisation

Time frame: 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)

Difference in number of increases in continuous positive airway pressure (CPAP) within 24 hours after - 24 hours before immunisation

Time frame: within 24 hours after - 24 hours before immunisation

Difference in number of reinstallations in continuous positive airway pressure (CPAP)

Difference in number of reinstallations in continuous positive airway pressure (CPAP) within 24 hours after - 24 hours before immunisation

Data from ClinicalTrials.gov

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