Actively Recruiting
Close Loop Smart Weaning for INO With PPHN
Led by Children's Hospital of Fudan University · Updated on 2026-05-13
30
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Close Loop Smart Weaning for INO With PPHN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Inhaled nitric oxide (iNO) treatment started or planned for 24 hours or more for persistent pulmonary hypertension of the newborn (PPHN)
- Positive response to iNO treatment
- Use of an iNO delivery system with intelligent closed-loop offline function
- Guardian or legal representative signed informed consent after understanding study benefits and risks
You will not qualify if you...
- Severe left heart hypoplasia or duct-dependent congenital heart disease
- Life-threatening congenital anomalies or congestive heart failure
- Congenital methemoglobinemia
- Significant bleeding events such as intracranial, intraventricular, or pulmonary hemorrhage
- Chronic lung diseases or other refractory diseases within 7 days after iNO treatment
- No response to iNO or iNO use less than 30 minutes (no withdrawal needed)
- iNO concentration above 20 ppm at start or withdrawal concentration below 20 ppm (special considerations required)
- Participation in other clinical trials with drugs or devices
- Investigator's judgment that study participation is not suitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, China
Actively Recruiting
Research Team
Z
Zhicheng Zhu
CONTACT
W
Weiling Kong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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