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RECRUITINGINTERVENTIONAL

Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

Early Detection and Prevention of Health Complications in Preterm Infants - Controlled Remote Monitoring and Optimization of Oxygen Therapy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Pulse oximeter

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.

Locations (4)

České Budějovice Hospital
České Budějovice, Czech Republic, Czechia
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