Predictive Value of Heart Rate Variability on Cardiorespiratory Events

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2022-11-05

Brief Summary

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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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Detailed Description

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Conditions

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Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental1

preterm infants will be routinely immunised during primary hospitalisation

immunisation

Intervention Type BIOLOGICAL

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

immunisation

Intervention Type BIOLOGICAL

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

Control

healthy control infants

immunisation

Intervention Type BIOLOGICAL

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

Interventions

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immunisation

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

3 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No