NCT07161908 Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
| NCT ID | NCT07161908 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Health Information and Statistics of the Czech Republic |
| Condition | BPD - Bronchopulmonary Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2026-11 |
Trial Parameters
Eligibility Fast-Check
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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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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