Actively Recruiting
Early Detection and Prevention of Health Complications in Preterm Infants - Controlled Remote Monitoring and Optimization of Oxygen Therapy
Led by Institute of Health Information and Statistics of the Czech Republic · Updated on 2025-09-09
70
Participants Needed
4
Research Sites
13 weeks
Total Duration
On this page
Sponsors
I
Institute of Health Information and Statistics of the Czech Republic
Lead Sponsor
Č
České Budějovice Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to develop and test a national approach for remotely monitoring and optimizing oxygen therapy in premature infants diagnosed with bronchopulmonary dysplasia in the Czech Republic. The goal is to reduce health risks and negative impacts on the child's development and family by improving care for preterm newborns. The project is a prospective, multicenter, interventional pilot involving four perinatology centers. Premature infants with bronchopulmonary dysplasia who require low-flow nasal cannulas for oxygen will be included. Their oxygen therapy will be managed remotely using specialized pulse oximeters that continuously monitor oxygen saturation. Treatment adjustments will follow established protocols to safely and earlier reduce oxygen therapy, including tests involving oxygen flow reduction and overnight monitoring. The project is supported by the European Social Fund and the Czech Republic government. Participants will be closely monitored from enrollment until four weeks after stopping home oxygen therapy. Researchers will track oxygen saturation levels continuously and assess the duration of oxygen therapy and the number of therapy failures before termination. The study includes remote monitoring, data collection, and adherence to protocols to optimize care and ensure safety throughout the process.
CONDITIONS
Brief Title
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born before 31 weeks and 6 days of gestation
- Signed consent for participation and processing of personal data
- Diagnosed with bronchopulmonary dysplasia
- Receiving oxygen therapy via low-flow nasal cannulas
You will not qualify if you...
- No signed consent for participation or processing of personal data
- Diagnosed with other conditions causing high risk of long-term low oxygen, such as major heart defects, brain development disorders, genetic diseases causing breathing problems, central apneas, or severe early obstructive sleep apnea
- Having other chronic respiratory diseases besides bronchopulmonary dysplasia, like cystic fibrosis or chronic aspiration
- Insufficient therapy through long-term home oxygen
- Having a tracheostomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment to 4 weeks after discontinuation of home oxygen therapy
Participants receive controlled remote oxygen therapy with continuous pulse oximeter monitoring to optimize and safely reduce oxygen levels at home.
Continuous remote monitoring with pulse oximeter and occasional hospital/home assessments during oxygen flow adjustments
Duration - 4 weeks after discontinuation of oxygen therapy
Participants are monitored for 4 weeks after complete weaning from oxygen supply to ensure stable oxygen levels and health.
Remote monitoring and periodic assessments as needed
Trial Site Locations
Total: 4 locations
1
České Budějovice Hospital
České Budějovice, Czech Republic, Czechia
Actively Recruiting
2
University Hospital Olomouc
Olomouc, Czech Republic, Czechia
Actively Recruiting
3
General University Hospital
Prague, Czech Republic, Czechia
Actively Recruiting
4
Institute for the Care of Mother and Child
Prague, Czech Republic, Czechia
Actively Recruiting
Research Team
D
Daniela Dokoupilová, MSc
L
Lucie Mandelová, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here