Clinical trial NCT04303494: Predictive Value of Heart Rate Variability on Cardiorespiratory Events
Official title: Predictive Value of Heart Rate Variability on Cardiorespiratory Events of Preterm Infants Routinely Immunised in the Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 292
Sex: ALL
Minimum age (years): 3
Maximum age (years): 28
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: preterm infants and healthy control infants

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in AOP
timeFrame: record the sum of AOP events from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation
Secondary outcomes:
measure: Difference in prolonged hypoxaemic episodes
timeFrame: record SpO2 from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation
measure: Difference in number of manual stimulations
timeFrame: number of manual stimulations within 24 hours after - 24 hours before immunisation
measure: Difference in number increases in oxygen concentration
timeFrame: record oxygen concentration from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation
measure: Difference in number of increases in continuous positive airway pressure (CPAP)
timeFrame: within 24 hours after - 24 hours before immunisation
measure: Difference in number of reinstallations in continuous positive airway pressure (CPAP)
timeFrame: within 24 hours after - 24 hours before immunisation
measure: Difference in number of endotracheal intubation
timeFrame: within 24 hours after - 24 hours before immunisation
measure: Difference in sample entropy (SampEn) of interbeat interval of heart rate (IBI)
timeFrame: 24 hours after - immediately prior to immunisation
measure: Difference in SampEn of IBI
timeFrame: preterm infants measured at 37 to 42 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel UKBB, University of Basel
Study officials:
affiliation: University Children's Hospital Basel, UKBB
name: Sven Schulzke, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References: