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Completed

NCT Number: NCT04303494

Predictive Value of Heart Rate Variability on Cardiorespiratory Events

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.

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Key information

Conditions

Post-immunisation Apnoea and Bradycardia of Prematurity (AOP) Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Basel UKBB, University of Basel

Basel, 4056, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immunisation

Biological

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2020
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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