Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)
Conditions
Brief summary
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.
Interventions
BIOLOGICALimmunisation
combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Days to 28 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in AOP | 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
| Measure | Time frame | Description |
|---|---|---|
| Difference in number of manual stimulations | 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 |
| Difference in number increases in oxygen concentration | 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 |
| Difference in number of increases in continuous positive airway pressure (CPAP) | 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 |
| Difference in prolonged hypoxaemic episodes | 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). |
| Difference in number of endotracheal intubation | 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 |
| Difference in sample entropy (SampEn) of interbeat interval of heart rate (IBI) | 24 hours after - immediately prior to immunisation | Difference in SampEn of IBI 24 hours after - immediately prior to immunisation |
| Difference in SampEn of IBI | 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 |
| Difference in number of reinstallations in continuous positive airway pressure (CPAP) | 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 |
Countries
Switzerland
Outcome results
None listed