Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

Institute of Health Information and Statistics of the Czech Republic

Status: Enrolling

Conditions: BPD - Bronchopulmonary Dysplasia; Pulmonary Hypertension

Treatments: Device: Pulse oximeter

Study type: Interventional

Funder types: Other

Identifiers

NCT07161908

UZIS 2025/1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: Under 36 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Controlled remote oxygen therapy

Experimental group

Description:

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

Treatment:

Device: Pulse oximeter