Close Loop Smart Weaning for INO With PPHN

NCT06832163 | Not Yet Recruiting

• 1 other identifier: Close-iNO Study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Pulmonary Hypertension of the Newborn; Inhaled Nitric Oxide

Keywords

Inhaled Nitric Oxide; Persistent Pulmonary Hypertension of the Newborn

Outcome Measures

Primary Outcomes (2)

• The occurrence of nitric oxide (NO) rebound hypoxia during the evacuation process

  The occurrence of nitric oxide (NO) rebound hypoxia during the evacuation process, operationally defined as the frequency of instances in which peripheral capillary oxygen saturation (SpO2) decreased by more than 5% and the fraction of inspired oxygen (FiO2) increased by 15% in order to maintain partial pressure of arterial oxygen (PaO2) above 60 mmHg (with SpO2 ≥ 90%) during the evacuation of NO

  Completion of evacuation (expected day 2 of evacuation)

• The total duration of inhaled nitric oxide (iNO) evacuation

  The entire length of time required to remove or discontinue the use of iNO.

  Completion of evacuation (expected day 2 of evacuation)

Secondary Outcomes (8)

• Device Alarm Frequency

  Completion of evacuation (expected day 2 of evacuation)

• NO Concentration Adjustments

  Completion of evacuation (expected day 2 of evacuation)

• Mechanical Ventilation Duration

  Completion of evacuation (expected day 2 of evacuation)

• Adverse Events Incidence

  Completion of evacuation (expected day 2 of evacuation)

• Complication Rate

  Completion of evacuation (expected day 2 of evacuation)

Study Arms (1)

Inhaled Nitric Oxide (iNO), the initial concentration of NO withdrawal is 20ppm.

EXPERIMENTAL

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.

Device: Nitric Oxide Generation and Delivery System

Interventions

Nitric Oxide Generation and Delivery System DEVICE

The Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. iNO devices with intelligent closed-loop offline function are required to meet the import and discharge standards. The initial concentration of NO withdrawal is 20ppm. In accordance with the withdrawal criteria outlined in the Chinese Guidelines, it is essential to conduct a comprehensive efficacy evaluation prior to initiating withdrawal. Furthermore, the process of inhaled nitric oxide (iNO) evacuation should commence only if specific conditions are satisfied.

Inhaled Nitric Oxide (iNO), the initial concentration of NO withdrawal is 20ppm.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• There are established contraindications associated with the use of nitric oxide, which include the following conditions:
• Severe hypoplasia of the left heart or duct-dependent congenital heart disease;
• Life-threatening congenital anomalies and congestive heart failure;
• Congenital methemoglobinemia;
• Significant hemorrhagic events, such as intracranial hemorrhage, intraventricular hemorrhage, and pulmonary hemorrhage.
• Patients with chronic pulmonary conditions and other refractory diseases are not permitted to initiate withdrawal from the inhaled nitric oxide (iNO) treatment within a seven-day period following its administration.
• In cases where there is no observable response to iNO or if the duration of use is less than 30 minutes, a strict tapering protocol for withdrawal is not required.
• If the concentration of iNO treatment exceeds 20 parts per million (ppm) during the initiation phase or if the starting concentration for withdrawal is below 20 ppm, specific considerations must be taken into account.
• Participation in concurrent clinical trials involving other pharmacological agents or medical devices is prohibited.
• The investigator may determine that participation in this study is not appropriate for certain individuals.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lin Yuan

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhicheng Zhu

CONTACT

+86 13601911685; jonney116@sina.com

Weiling Kong

CONTACT

+8613547827448; kongwling@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)