RecruitingNot ApplicableNCT07161908

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

Sponsor

Institute of Health Information and Statistics of the Czech Republic

Enrollment

70 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension BPD - Bronchopulmonary Dysplasia

Summary

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

Max Age: 36 Weeks

Plain Language Summary

Simplified for easier understanding

This study tests whether remote monitoring technology can help doctors better manage oxygen levels in premature babies who have a chronic lung condition called bronchopulmonary dysplasia (BPD) — a common problem in very early preterm infants who needed breathing support after birth. **You may be eligible if...** - Your baby was born before 32 weeks of pregnancy - Your baby has been diagnosed with bronchopulmonary dysplasia - Your baby is currently using low-flow nasal oxygen (through small tubes in the nose) - You have signed consent for participation **You may NOT be eligible if...** - Consent has not been given - Your baby has other conditions that cause long-term low oxygen levels, such as significant heart defects, central nervous system developmental disorders, genetic diseases linked to breathing problems, or severe sleep apnea Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPulse 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.