Predictive Value of Heart Rate Variability on Cardiorespiratory Events

March 31, 2023 updated by: University Hospital, Basel, Switzerland

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

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 Overview

Study Type

Observational

Enrollment (Actual)

292

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Basel, Switzerland, 4056
        • University Children's Hospital Basel UKBB, University of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 4 weeks (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

preterm infants and healthy control infants

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental1
preterm infants will be routinely immunised during primary hospitalisation
combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination
Experimental2
preterm infants discharged and readmitted for immunisation during the 3-year period
combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination
Control
healthy control infants
combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sven Schulzke, Prof. Dr. med, University Children's Hospital Basel, UKBB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

November 5, 2022

Study Completion (Actual)

November 5, 2022

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-01207; ks17Schulzke

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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