Remote-controlled oxygen therapy for preterm infants with BPD
Early Detection and Prevention of Health Complications in Preterm Infants - Controlled Remote Monitoring and Optimization of Oxygen Therapy
This project will test whether remote monitoring and protocol-driven adjustments of home oxygen can safely help preterm infants with bronchopulmonary dysplasia stop oxygen sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | N/A to 36 Weeks |
| Sex | All |
| Sponsor | Institute of Health Information and Statistics of the Czech Republic Government |
| Locations | 4 sites (České Budějovice, Czech Republic and 3 other locations) |
| Trial ID | NCT07161908 on ClinicalTrials.gov |
What this trial studies
This national, prospective, multicenter pilot in the Czech Republic will enroll about 70 preterm infants with bronchopulmonary dysplasia who are discharged on low-flow nasal cannulas. Continuous home pulse oximetry data will be transmitted to clinicians who will adjust oxygen using pre-established protocols aimed at earlier and safer weaning. The project aims to validate the organization and feasibility of remotely managed home oxygen therapy and to prepare a proposal for a national care methodology. It is supported by national and European funds and has received ethical approvals from local committees.
Who should consider this trial
Good fit: Ideal candidates are infants born before 31+6 weeks with a diagnosis of BPD who are ready for discharge on low-flow nasal cannulas and whose parents consent to remote monitoring.
Not a fit: Patients with major coexisting conditions that cause long-term hypoxia (significant congenital heart disease, certain neurological or genetic disorders), other chronic respiratory diseases, tracheostomy, or those not on low-flow nasal cannulas are unlikely to benefit.
Why it matters
Potential benefit: If successful, it could shorten the time infants need supplemental oxygen, reduce health risks, and lessen the developmental and family impact of prolonged oxygen use.
How similar studies have performed: Similar telemedicine and home oximetry programs in neonatal and pediatric care have shown promising small-scale results but remain relatively novel and not yet widely implemented.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
České Budějovice, Czech Republic and 3 other locations
- České Budějovice Hospital — České Budějovice, Czech Republic, Czechia (Recruiting)
- University Hospital Olomouc — Olomouc, Czech Republic, Czechia (Recruiting)
- General University Hospital — Prague, Czech Republic, Czechia (Recruiting)
- Institute for the Care of Mother and Child — Prague, Czech Republic, Czechia (Recruiting)
Study contacts
- Study coordinator: Daniela Dokoupilová, MSc
- Email: daniela.dokoupilova@uzis.cz
- Phone: +420725441408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.