Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07161908
NA

Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

Sponsor: Institute of Health Information and Statistics of the Czech Republic

View on ClinicalTrials.gov

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.

Official title: Early Detection and Prevention of Health Complications in Preterm Infants - Controlled Remote Monitoring and Optimization of Oxygen Therapy

Key Details

Gender

All

Age Range

Any - 36 Weeks

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-08-25

Completion Date

2027-02

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

DEVICE

Pulse 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.

Locations (4)

České Budějovice Hospital

České Budějovice, Czech Republic, Czechia

University Hospital Olomouc

Olomouc, Czech Republic, Czechia

General University Hospital

Prague, Czech Republic, Czechia

Institute for the Care of Mother and Child

Prague, Czech Republic, Czechia