Predictive Value of Heart Rate Variability on Cardiorespiratory Events

University Hospital Basel

Status: Completed

Conditions: Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)

Treatments: Biological: immunisation

Study type: Observational

Funder types: Other

Identifiers

NCT04303494

2018-01207 ks17Schulzke;

Details and patient eligibility

About

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.

Enrollment: 292 patients

Sex: All

Ages: 3 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

292 participants in 3 patient groups

Experimental1

Description:

preterm infants will be routinely immunised during primary hospitalisation

Treatment:

Biological: immunisation

Experimental2

Description:

preterm infants discharged and readmitted for immunisation during the 3-year period

Treatment:

Biological: immunisation

Control

Description:

healthy control infants

Treatment:

Biological: immunisation