Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

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.

Conditions

• BPD - Bronchopulmonary Dysplasia
• Pulmonary Hypertension

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.

Sponsors & Collaborators

• České Budějovice Hospital

  collaborator OTHER

• University Hospital Olomouc

  collaborator OTHER

• Institute for the Care of Mother and Child, Prague, Czech Republic

  collaborator OTHER

• General University Hospital, Prague

  collaborator OTHER

• Institute of Health Information and Statistics of the Czech Republic

  lead OTHER_GOV

Principal Investigators

• Richard Plavka, prof. · General Hospital University in Prague

• Jana Tuková, Ph.D. · General Hospital University in Prague

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

36 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-25

Primary Completion

2026-11-30

Completion

2027-02-28

Countries

• Czechia

Study Locations