Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 va

Первичные конечные точки

• Average duration of controlled oxygen therapy in a premature infant [Срок оценки: From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)]

Вторичные конечные точки (1)

• Average number of failures in premature infants before the termination of controlled oxygen therapy [Срок оценки: From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Чехия · 4 центра

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

Идентификаторы

NCT: NCT07161908 · UZIS 2025/1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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