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NCT Number: NCT07161908

Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

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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Key information

Conditions

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

Age range

Up to 36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Olomouc, Olomouc, Czech Republic, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Average duration of controlled oxygen therapy in a premature infant

    Time frame: 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

Secondary outcomes

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

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

    Failure is defined as the need to return to the original flow rate before the last reduction.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Dokoupilová, MSc

CONTACT

[email protected]

+420725441408

Lucie Mandelová, Ph.D.

CONTACT

[email protected]

+420770190828

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

  • General University Hospital, Prague
  • Institute for the Care of Mother and Child, Prague, Czech Republic
  • University Hospital Olomouc
  • České Budějovice Hospital

Registry information

Official study title

Early Detection and Prevention of Health Complications in Preterm Infants - Controlled Remote Monitoring and Optimization of Oxygen Therapy

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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