Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

NCT07161908 | Recruiting

• 1 other identifier: UZIS 2025/1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

BPD; Bronchopulmonary Dysplasia; preterm infants; oxygen therapy; telemedicine; remote monitoring; pulmonary hypertension; Czech Republic

Outcome Measures

Primary Outcomes (1)

• Average duration of controlled oxygen therapy in a premature infant

  Number of days a premature infant stays on oxygen therapy

  From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)

Secondary Outcomes (1)

• Average number of failures in premature infants before the termination of controlled oxygen therapy

  From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)

Study Arms (1)

Controlled remote oxygen therapy

EXPERIMENTAL

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

Device: Pulse oximeter

Interventions

Pulse oximeter 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.

Controlled remote oxygen therapy

Eligibility Criteria

• Age: Up to 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Health Information and Statistics of the Czech Republic: lead
• České Budějovice Hospital: collaborator
• University Hospital Olomouc: collaborator
• Institute for the Care of Mother and Child, Prague, Czech Republic: collaborator
• General University Hospital, Prague: collaborator

Study Sites (4)

České Budějovice Hospital

České Budějovice, Czech Republic, Czechia

RECRUITING

University Hospital Olomouc

Olomouc, Czech Republic, Czechia

RECRUITING

General University Hospital

Prague, Czech Republic, Czechia

RECRUITING

Institute for the Care of Mother and Child

Prague, Czech Republic, Czechia

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Richard Plavka, prof.

  General Hospital University in Prague

  STUDY DIRECTOR

• Jana Tuková, Ph.D.

  General Hospital University in Prague

  STUDY CHAIR

Central Study Contacts

Daniela Dokoupilová, MSc

CONTACT

+420725441408; daniela.dokoupilova@uzis.cz

Lucie Mandelová, Ph.D.

CONTACT

+420770190828; lucie.mandelova@uzis.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 9, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

CZ (4)