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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Pulse oximeter
DeviceTo 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.
Treatment groups
Trial outcomes
Primary outcomes
Average duration of controlled oxygen therapy in a premature infant
Number of days a premature infant stays on oxygen therapy
Secondary outcomes
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.
Sponsors and contacts
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Institute of Health Information and Statistics of the Czech Republic
Lead sponsor
České Budějovice Hospital
Collaborator
University Hospital Olomouc
Collaborator
Institute for the Care of Mother and Child, Prague, Czech Republic
Collaborator
General University Hospital, Prague
Collaborator