Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT06114992
Brief Summary:
The purpose of this study is to evaluate the safety and performance of High-Frequency Oscillatory Ventilation (HFOV) modes of the Servo-n ventilator in neonates and infants, by using a prospective, observational, single-arm (i.e., non-controlled) and multi-center Post-Market Follow-up (PMCF) study design. HFOV treatment will be evaluated by assessing ventilation and oxygenation variables, and safety will be evaluated by documentation of device related adverse events.
Detailed Description:
The purpose of this study is to evaluate the safety and performance of HFOV modes of the Servo-n ventilator in neonates and infants. This is a prospective, observational, single-arm (i.e., non-controlled) and multi-center PMCF study in neonates and infants between 0.3 to 8 kg. All study procedures are within each hospital's routine clinical practice.The primary endpoints includes variables which are routinely used per clinical practice for assessing the status of patient's ventilation and oxygenation, respectively. Secondary endpoints are used to evaluate safety of Servo-n HFOV during its use by assessing rates of adverse event/ device deficiencies related to the Servo-n HFOV device, and by assessing rates of mortality, Bronchopulmonary Dysplasia (BPD) and Retinopathy at Intensive Care Unit (ICU) discharge. Data collection will take place up to 24 hours prior to HFOV treatment, during HFOV and up to ICU discharge. Additional general data such as ventilator settings, reasons for initiating/terminating HFOV treatment and demographics will also be recorded.
Study:
NCT06114992
Study Brief:
Protocol Section:
NCT06114992