Status:
RECRUITING
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
Lead Sponsor:
Institute of Health Information and Statistics of the Czech Republic
Collaborating Sponsors:
České Budějovice Hospital
University Hospital Olomouc
Conditions:
BPD - Bronchopulmonary Dysplasia
Pulmonary Hypertension
Eligibility:
All Genders
Up to 36 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07161908
Start Date
August 25 2025
End Date
February 1 2027
Last Update
September 9 2025
Active Locations (4)
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1
České Budějovice Hospital
České Budějovice, Czech Republic, Czechia
2
University Hospital Olomouc
Olomouc, Czech Republic, Czechia
3
General University Hospital
Prague, Czech Republic, Czechia
4
Institute for the Care of Mother and Child
Prague, Czech Republic, Czechia