Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 36
SponsorInstitute of Health Information and Statistics of the Czech Republic

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

Qualifiers

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

Treatments tested in this trial

  • Pulse oximeter

Treatment groups

70 Participants
are divided into 1 treatment group

Sponsors and collaborators

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