Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Average duration of controlled oxygen therapy in a premature infant — From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)
  Number of days a premature infant stays on oxygen therapy

Trial sites (4)

More Institute of Health Information and Statistics of the Czech Republic trials in Czechia

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