- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04303494
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
Status
Completed
Intervention / Treatment
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
- Name: Sven Schulzke, Prof. Dr. med
- Phone Number: +41 61 556 5486
- Email: sven.schulzke@unibas.ch
Study Contact Backup
- Name: Sirée Kämpfen, Dr. med.
- Phone Number: +41 61 704 23 06
- Email: Siree.Kaempfen@ukbb.ch
Study Locations
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Basel, Switzerland, 4056
- University Children's Hospital Basel UKBB, University of Basel
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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
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combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination
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Experimental2
preterm infants discharged and readmitted for immunisation during the 3-year period
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combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination
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Control
healthy control infants
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combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination
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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
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Difference in AOP events within 24 hours after - 24 hours before immunisation
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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
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Difference in prolonged hypoxaemic episodes (SpO2 < 80% for at least 1 min) within 24 hours after - 24 hours before immunisation (CAP-trial definition).
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record SpO2 from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation
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Difference in number of manual stimulations
Time Frame: number of manual stimulations within 24 hours after - 24 hours before immunisation
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Difference in number of manual stimulations within 24 hours after - 24 hours before immunisation
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number of manual stimulations within 24 hours after - 24 hours before immunisation
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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
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Difference in number increases in oxygen concentration within 24 hours after - 24 hours before immunisation
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record oxygen concentration from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation
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Difference in number of increases in continuous positive airway pressure (CPAP)
Time Frame: within 24 hours after - 24 hours before immunisation
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Difference in number of increases in continuous positive airway pressure (CPAP) within 24 hours after - 24 hours before immunisation
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within 24 hours after - 24 hours before immunisation
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Difference in number of reinstallations in continuous positive airway pressure (CPAP)
Time Frame: within 24 hours after - 24 hours before immunisation
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Difference in number of reinstallations in continuous positive airway pressure (CPAP) within 24 hours after - 24 hours before immunisation
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within 24 hours after - 24 hours before immunisation
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Difference in number of endotracheal intubation
Time Frame: within 24 hours after - 24 hours before immunisation
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Difference in number of endotracheal intubation for AOP events within 24 hours after - 24 hours before immunisation
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within 24 hours after - 24 hours before immunisation
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Difference in sample entropy (SampEn) of interbeat interval of heart rate (IBI)
Time Frame: 24 hours after - immediately prior to immunisation
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Difference in SampEn of IBI 24 hours after - immediately prior to immunisation
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24 hours after - immediately prior to immunisation
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Difference in SampEn of IBI
Time Frame: preterm infants measured at 37 to 42 weeks
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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
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preterm infants measured at 37 to 42 weeks
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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
Additional Relevant MeSH Terms
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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