Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
Recruiting · NCT07161908 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Health Information and Statistics of the Czech Republic
View the official record on ClinicalTrials.gov →Interventions studied
Pulse oximeter
What this trial is about
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.
Who can take part
Age range
Up to 36 Weeks
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed.
- University Hospital Olomouc - Olomouc, Czech Republic, Czechia
- General University Hospital - Prague, Czech Republic, Czechia
- Institute for the Care of Mother and Child - Prague, Czech Republic, Czechia
- České Budějovice Hospital - České Budějovice, Czech Republic, Czechia