Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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The project is a national, prospective, multicenter, interventional pilot project focused on remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic.

The main goal of the project is validation of the possibility and organization of remotely managed home oxygen therapy and its optimization, aiming for its earlier termination.

The project will be running in 4 perinatology centers in the Czech Republic. It is expected that 70 premature infants diagnosed with bronchopulmonary dysplasia will participate. The infant must transition to low-flow nasal cannulas to be discharged to home care. Oxygen therapy will be adjusted based on pre-established protocols aiming for earlier and safer termination of oxygen therapy through precise remote continual monitoring.

The project is supported by the European Social Fund (Operational Program Employment Plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22\_005/0002020.

The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.

Conditions

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BPD - Bronchopulmonary Dysplasia Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Controlled remote oxygen therapy

The patients will be following study protocol of optimization of oxygen therapy.

Group Type EXPERIMENTAL

Pulse oximeter

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* infants born before 31+6 weeks gestation
* signed consent for participation in the project and consent for the processing of personal data
* diagnosed with bronchopulmonary dysplasia
* type of pulmonary ventilation - low-flow nasal cannulas

Exclusion Criteria

* unsigned consent for participation in the project and/or consent for the processing of personal data
* child diagnosed with conditions other than bronchopulmonary dysplasia (BPD) at high risk of long-term hypoxia - selected chronic cardiovascular, neurological, and muscular diseases, e.g., significant congenital heart defects, congenital central nervous system developmental disorders, genetic diseases associated with the risk of hypoventilation, central apneas, severe early obstructive sleep apnea
* other chronic respiratory diseases besides BPD - e.g., cystic fibrosis, chronic aspiration
* insufficient therapy through long-term home oxygen therapy
* tracheostomy

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No