Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)NCT04303494
Predictive Value of Heart Rate Variability on Cardiorespiratory Events
An observational study of Post-immunisation Apnoea and Bradycardia of Prematurity (AOP), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 28 days
- Conditions the study is for
- Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)
- What is being tested?
- immunisation
- Type of treatment
- Vaccines
- How many people
- 292 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2018to 5 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 28 days
- All sexes
- Child
Study population: preterm infants and healthy control infants
Who may be able to join
- 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
Who cannot join
- Major congenital malformations including neuromuscular disorders, thoracic malformations, major cardiac malformation
- Lack of written informed parental consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Basel UKBB, University of Basel
Basel, 4056
About this study
Official title: Predictive Value of Heart Rate Variability on Cardiorespiratory Events of Preterm Infants Routinely Immunised in the Hospital
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.
- Being tested
- immunisation
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunisationBiological
combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination
| Study group | Role | What they receive |
|---|---|---|
| Experimental1 | preterm infants will be routinely immunised during primary hospitalisation Receives: Biological: immunisation | |
| Experimental2 | preterm infants discharged and readmitted for immunisation during the 3-year period Receives: Biological: immunisation | |
| Control | healthy control infants Receives: Biological: immunisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in AOP
Difference in AOP events within 24 hours after - 24 hours before immunisation
Measured: record the sum of AOP events from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation
Secondary outcomes (8)
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).
Measured: record SpO2 from 48 hours windows of raw data, within 24 hours after - 24 hours before immunisation
Difference in number of manual stimulations
Difference in number of manual stimulations within 24 hours after - 24 hours before immunisation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: preterm infants measured at 37 to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Jul 2018
- Primary completion5 Nov 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven Schulzke, Prof. Dr. med, Principal investigator, University Children's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303494
- Sponsor's protocol ID
- 2018-01207; ks17Schulzke
- Other IDs
- 2018
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2020
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39805735
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Heart Rate Variability on Cardiorespiratory Events of Preterm Infants Routinely Immunised in the Hospital
- ClinicalTrials.gov ID
- NCT04303494
- Acronym / sponsor ID
- 2018-01207; ks17Schulzke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental1 | – | Biological: immunisationpreterm infants will be routinely immunised during primary hospitalisation |
| Experimental2 | – | Biological: immunisationpreterm infants discharged and readmitted for immunisation during the 3-year period |
| Control | – | Biological: immunisationhealthy control infants |
Who may qualify
- Ages
- 3 to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- preterm infants and healthy control infants
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Major congenital malformations including neuromuscular disorders, thoracic malformations, major cardiac malformation
- Lack of written informed parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunisationcombined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination | Biological | Control, Experimental1, Experimental2 |
Primary outcome
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
8 secondary outcomes
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 number of manual stimulations
Time frame: number of manual stimulations within 24 hours after - 24 hours before immunisation
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 of increases 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)
Time frame: within 24 hours after - 24 hours before immunisation
Difference in number of endotracheal intubation
Time frame: within 24 hours after - 24 hours before immunisation
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
Time frame: preterm infants measured at 37 to 42 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Derived from this study: PubMed 39805735Kaempfen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Schulzke, Prof. Dr. med principal investigator
University Children's Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-immunisation Apnoea and Bradycardia of Prematurity (AOP), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04303494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.