Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental1 | preterm infants will be routinely immunised during primary hospitalisation |
| |
| Experimental2 | preterm infants discharged and readmitted for immunisation during the 3-year period |
| |
| Control | healthy control infants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunisation | Biological | combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in AOP | Difference in AOP events within 24 hours after - 24 hours before immunisation | record the sum of AOP events from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in prolonged hypoxaemic episodes | Difference in prolonged hypoxaemic episodes (SpO2 < 80% for at least 1 min) within 24 hours after - 24 hours before immunisation (CAP-trial definition). | record SpO2 from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation |
| Difference in number of manual stimulations |
Not provided
Inclusion criteria for preterm infants:
Inclusion criteria for term healthy control infants:
Exclusion Criteria:
Not provided
Not provided
Not provided
preterm infants and healthy control infants
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sven Schulzke, Prof. Dr. med | University Children's Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Basel UKBB, University of Basel | Basel | 4056 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39805735 | Derived | Kaempfen S, Hug M, Sanchez C, Delgado-Eckert E, Schulzke SM. Heart Rate Variability Does Not Predict Recurrence of Apnoea of Prematurity After Ceasing Caffeine Therapy: A Prospective Cohort Study. Acta Paediatr. 2025 Jun;114(6):1371-1378. doi: 10.1111/apa.17579. Epub 2025 Jan 13. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D014611 | Vaccination |
| ID | Term |
|---|---|
| D016233 | Immunotherapy, Active |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
Not provided
Not provided
Not provided
Not provided
Not provided
Difference in number of manual stimulations within 24 hours after - 24 hours before immunisation |
| number of manual stimulations within 24 hours after - 24 hours before immunisation |
| Difference in number increases in oxygen concentration | Difference in number increases in oxygen concentration within 24 hours after - 24 hours before immunisation | record oxygen concentration from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation |
| Difference in number of increases in continuous positive airway pressure (CPAP) | Difference in number of increases in continuous positive airway pressure (CPAP) within 24 hours after - 24 hours before immunisation | within 24 hours after - 24 hours before immunisation |
| Difference in number of reinstallations in continuous positive airway pressure (CPAP) | Difference in number of reinstallations in continuous positive airway pressure (CPAP) within 24 hours after - 24 hours before immunisation | within 24 hours after - 24 hours before immunisation |
| Difference in number of endotracheal intubation | Difference in number of endotracheal intubation for AOP events within 24 hours after - 24 hours before immunisation | within 24 hours after - 24 hours before immunisation |
| Difference in sample entropy (SampEn) of interbeat interval of heart rate (IBI) | Difference in SampEn of IBI 24 hours after - immediately prior to immunisation | 24 hours after - immediately prior to immunisation |
| Difference in SampEn of IBI | 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 | preterm infants measured at 37 to 42 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001691 |
| Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |