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| Name | Class |
|---|---|
| České Budějovice Hospital | OTHER |
| University Hospital Olomouc | OTHER |
| Institute for the Care of Mother and Child, Prague, Czech Republic | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlled remote oxygen therapy | Experimental | The patients will be following study protocol of optimization of oxygen therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse oximeter | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average duration of controlled oxygen therapy in a premature infant | Number of days a premature infant stays on oxygen therapy | From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Dokoupilová, MSc | Contact | +420725441408 | daniela.dokoupilova@uzis.cz | |
| Lucie Mandelová, Ph.D. | Contact | +420770190828 | lucie.mandelova@uzis.cz |
| Name | Affiliation | Role |
|---|---|---|
| Richard Plavka, prof. | General Hospital University in Prague | Study Director |
| Jana Tuková, Ph.D. | General Hospital University in Prague | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| České Budějovice Hospital | Recruiting | České Budějovice | Czech Republic | Czechia |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| General University Hospital, Prague |
| OTHER |
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| University Hospital Olomouc | Recruiting | Olomouc | Czech Republic | Czechia |
|
| General University Hospital | Recruiting | Prague | Czech Republic | Czechia |
|
| Institute for the Care of Mother and Child | Recruiting | Prague | Czech Republic | Czechia |
|
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |