BPD - Bronchopulmonary DysplasiaNCT07161908
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
A study testing Pulse oximeter in people with BPD - Bronchopulmonary Dysplasia and Pulmonary Hypertension, run by Institute of Health Information and Statistics of the Czech Republic at 4 sites in Czechia.
Trial summary
The project is a national, prospective, multicenter, interventional pilot project focused on controlled remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic. Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
- What is being tested?
- Pulse oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesCzechia
- Study dates
- 25 Aug 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants born before 31+6 weeks gestation
- signed consent for participation in the project and consent for the processing of personal data
- diagnosed with bronchopulmonary dysplasia
- type of pulmonary ventilation - low-flow nasal cannulas
Who cannot join
- unsigned consent for participation in the project and/or consent for the processing of personal data
- child diagnosed with conditions other than bronchopulmonary dysplasia (BPD) at high risk of long-term hypoxia - selected chronic cardiovascular, neurological, and muscular diseases, e.g., significant congenital heart defects, congenital central nervous system developmental disorders, genetic diseases associated with the risk of hypoventilation, central apneas, severe early obstructive sleep apnea
- other chronic respiratory diseases besides BPD - e.g., cystic fibrosis, chronic aspiration
- insufficient therapy through long-term home oxygen therapy
- tracheostomy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia4 sites, 4 recruiting
- Recruiting
České Budějovice Hospital
České Budějovice, Czech Republic
Jiří Dušek, MD, dusek.jiri@nemcb.cz
- Recruiting
University Hospital Olomouc
Olomouc, Czech Republic
Martin Wita, MD, martin.wita@fnol.cz
- Recruiting
General University Hospital
Prague, Czech Republic
Jana Tukova, Ph.D., jana.tukova@vfn.cz
- Recruiting
Institute for the Care of Mother and Child
Prague, Czech Republic
Marta Jacevičová, MD, marta.jacevicova@upmd.eu
About this study
Official title: Early Detection and Prevention of Health Complications in Preterm Infants - Controlled Remote Monitoring and Optimization of Oxygen Therapy
The project is a national, prospective, multicenter, interventional pilot project focused on controlled remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic. The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of preterm newborns. This will reduce health risks in premature infants and minimize the negative impacts on the overall development of the child and the family of the premature infant.
Read the detailed description
The project is a national, prospective, multicenter, interventional pilot project focused on remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic.
The main goal of the project is validation of the possibility and organization of remotely managed home oxygen therapy and its optimization, aiming for its earlier termination.
The project will be running in 4 perinatology centers in the Czech Republic. It is expected that 70 premature infants diagnosed with bronchopulmonary dysplasia will participate. The infant must transition to low-flow nasal cannulas to be discharged to home care. Oxygen therapy will be adjusted based on pre-established protocols aiming for earlier and safer termination of oxygen therapy through precise remote continual monitoring.
The project is supported by the European Social Fund (Operational Program Employment Plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002020.
The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.
- Being tested
- Pulse oximeter
- Keywords
- BPD, Bronchopulmonary Dysplasia, preterm infants, oxygen therapy, telemedicine, remote monitoring, pulmonary hypertension, Czech Republic
- Medical subject headings
- Bronchopulmonary Dysplasia, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeterDevice
To ensure proper treatment, the infant will be continuously monitored with a pulse oximeter. Based on oxygen saturation levels, the treatment may be adjusted according to pre-established protocols. It is required that the saturation stays above a certain value for more than 95 % of the 12-hour measurement period. If the defined saturation values are reached, the parents will reduce the oxygen flow by one degree for 20 minutes in the hospital/home setting (20 minute test) and if the saturation values remain at 93 % or more during this period, overnight 12 hour monitoring will also be performed to confirm stable saturation values of 93 % or more for 95 % or more of the monitoring time.
Thanks to modern specialized pulse oximeters, it is possible to ensure accurate, long-term, remotely managed monitoring of the infant and to interactively optimize oxygen therapy based on current oxygen saturation levels.
| Study group | Role | What they receive |
|---|---|---|
| Controlled remote oxygen therapy | Experimental | The patients will be following study protocol of optimization of oxygen therapy. Receives: Device: Pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average duration of controlled oxygen therapy in a premature infant
Number of days a premature infant stays on oxygen therapy
Measured: From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)
Secondary outcomes (1)
Average number of failures in premature infants before the termination of controlled oxygen therapy
Failure is defined as the need to return to the original flow rate before the last reduction.
Measured: From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start25 Aug 2025
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPD - Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- České Budějovice Hospital, University Hospital Olomouc, Institute for the Care of Mother and Child, Prague, Czech Republic, General University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Richard Plavka, prof., Study director, General Hospital University in PragueJana Tuková, Ph.D., Study chair, General Hospital University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161908
- Sponsor's protocol ID
- UZIS 2025/1
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Prevention of Health Complications in Preterm Infants - Controlled Remote Monitoring and Optimization of Oxygen Therapy
- ClinicalTrials.gov ID
- NCT07161908
- Acronym / sponsor ID
- UZIS 2025/1
- Keywords
- BPD, Bronchopulmonary Dysplasia, preterm infants, oxygen therapy, telemedicine, remote monitoring, pulmonary hypertension, Czech Republic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- České Budějovice Hospital, University Hospital Olomouc, Institute for the Care of Mother and Child, Prague, Czech Republic, General University Hospital, Prague
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Sep 2025 (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 project is a national, prospective, multicenter, interventional pilot project focused on controlled remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic. The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of preterm newborns. This will reduce health risks in premature infants and minimize the negative impacts on the overall development of the child and the family of the premature infant.
Detailed description
The project is a national, prospective, multicenter, interventional pilot project focused on remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic.
The main goal of the project is validation of the possibility and organization of remotely managed home oxygen therapy and its optimization, aiming for its earlier termination.
The project will be running in 4 perinatology centers in the Czech Republic. It is expected that 70 premature infants diagnosed with bronchopulmonary dysplasia will participate. The infant must transition to low-flow nasal cannulas to be discharged to home care. Oxygen therapy will be adjusted based on pre-established protocols aiming for earlier and safer termination of oxygen therapy through precise remote continual monitoring.
The project is supported by the European Social Fund (Operational Program Employment Plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002020.
The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controlled remote oxygen therapy | Experimental | Device: Pulse oximeterThe patients will be following study protocol of optimization of oxygen therapy. |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- infants born before 31+6 weeks gestation
- signed consent for participation in the project and consent for the processing of personal data
- diagnosed with bronchopulmonary dysplasia
- type of pulmonary ventilation - low-flow nasal cannulas
Key exclusion criteria (5 listed)
- unsigned consent for participation in the project and/or consent for the processing of personal data
- child diagnosed with conditions other than bronchopulmonary dysplasia (BPD) at high risk of long-term hypoxia - selected chronic cardiovascular, neurological, and muscular diseases, e.g., significant congenital heart defects, congenital central nervous system developmental disorders, genetic diseases associated with the risk of hypoventilation, central apneas, severe early obstructive sleep apnea
- other chronic respiratory diseases besides BPD - e.g., cystic fibrosis, chronic aspiration
- insufficient therapy through long-term home oxygen therapy
- tracheostomy
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 |
|---|---|---|
| Pulse oximeterTo ensure proper treatment, the infant will be continuously monitored with a pulse oximeter. Based on oxygen saturation levels, the treatment may be adjusted according to pre-established protocols. It is required that the saturation stays above a certain value for more than 95 % of the 12-hour measurement period. If the defined saturation values are reached, the parents will reduce the oxygen flow by one degree for 20 minutes in the hospital/home setting (20 minute test) and if the saturation values remain at 93 % or more during this period, overnight 12 hour monitoring will also be performed to confirm stable saturation values of 93 % or more for 95 % or more of the monitoring time. Thanks to modern specialized pulse oximeters, it is possible to ensure accurate, long-term, remotely managed monitoring of the infant and to interactively optimize oxygen therapy based on current oxygen saturation levels. | Device | Controlled remote oxygen therapy |
Primary outcome
Average duration of controlled oxygen therapy in a premature infant
Time frame: From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)
Number of days a premature infant stays on oxygen therapy
1 secondary outcome
Average number of failures in premature infants before the termination of controlled oxygen therapy
Time frame: From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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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.
Richard Plavka, prof. study director
General Hospital University in Prague
Jana Tuková, Ph.D. study chair
General Hospital University in Prague
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse oximeter in people with BPD - Bronchopulmonary Dysplasia and Pulmonary Hypertension, run by Institute of Health Information and Statistics of the Czech Republic at 4 sites in Czechia.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Dokoupilová, MSc (+420725441408, daniela.dokoupilova@uzis.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average duration of controlled oxygen therapy in a premature infant (time frame: From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2025.