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Close Loop Smart Weaning Protocol for Inhaled Nitric Oxide Therapy With PPHN

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In contemporary clinical practice concerning the administration of inhaled nitric oxide (iNO) within neonatal intensive care units (NICUs), a stepwise reduction approach is frequently employed in accordance with established neonatal guidelines. Nonetheless, the comparative advantages of a linear reduction strategy-characterized by a gradual decrease in inhalation concentration-over the traditional stepwise method in terms of efficacy and safety have yet to be conclusively established. Furthermore, existing iNO delivery devices necessitate that healthcare professionals manually adjust parameters at intervals dictated by the patient's condition. This reliance on subjective clinical judgment often results in variability and a lack of standardization in the duration of the weaning process. Additionally, the protracted and intricate nature of the weaning procedure considerably heightens the workload for healthcare staff. Importantly, the development of a scientifically grounded, standardized, and real-time feedback mechanism for weaning may enhance clinical outcomes for patients and mitigate the risks associated with inappropriate weaning practices or inconsistent manual interventions. Consequently, this study seeks to leverage the newly introduced intelligent closed-loop weaning feature of the latest generation of iNO devices to facilitate automated linear concentration reduction during the weaning process. This innovation aims to alleviate the burden on healthcare personnel while establishing a more standardized and scientifically robust weaning protocol. However, it is noteworthy that there is currently a lack of clinical evidence, both domestically and internationally, regarding the safety and efficacy of this device's weaning protocol, underscoring the urgent need to validate its safety and effectiveness in real-world clinical settings.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• The administration of inhaled nitric oxide (iNO) has commenced or is anticipated to commence for a duration of 24 hours or more, based on a clinical diagnosis of persistent pulmonary hypertension of the newborn (PPHN);

• There is a demonstrable positive response to iNO treatment;

• The iNO delivery system employed is appropriate and meets the conditional requirements, featuring an intelligent closed-loop offline functionality;

• The guardian or legal representative possesses a comprehensive understanding of the potential benefits and risks associated with participation in this study and has expressed a willingness to consent by signing the informed consent document.

Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Zhicheng Zhu
jonney116@sina.com
+86 13601911685
Backup
Weiling Kong
kongwling@163.com
+8613547827448
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Inhaled Nitric Oxide (iNO), the initial concentration of NO withdrawal is 20ppm.
In the initial phase of the study, a total of 10 participants are enrolled in a non-controlled single-group pre-trial.~The subsequent phase is organized into two distinct groups, each comprising 10 participants, resulting in a total of 20 subjects. The groups are categorized as follows:~① The experimental group, which utilizes an intelligent closed-loop offline system operating in a linear decline mode;~② The control group, which employs an intelligent closed-loop offline system functioning in a step decline mode.
Sponsors
Leads: Children's Hospital of Fudan University

This content was sourced from clinicaltrials.gov