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NCT Number: NCT06832163

Close Loop Smart Weaning for INO With PPHN

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.

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Key information

Conditions

Persistent Pulmonary Hypertension of the Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypertension, Pulmonary Infant, Newborn, Diseases Inhaled Nitric Oxide Lung Diseases Persistent Fetal Circulation Syndrome Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Completion of evacuation (expected day 2 of evacuation)

    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

  2. The total duration of inhaled nitric oxide (iNO) evacuation

    Time frame: Completion of evacuation (expected day 2 of evacuation)

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

Secondary outcomes

  1. Device Alarm Frequency

    Time frame: Completion of evacuation (expected day 2 of evacuation)

    The frequency of device alarms recorded during the evacuation process.

  2. NO Concentration Adjustments

    Time frame: Completion of evacuation (expected day 2 of evacuation)

    The total number of adjustments made to knobs and settings for nitric oxide concentration during evacuation.

  3. Mechanical Ventilation Duration

    Time frame: Completion of evacuation (expected day 2 of evacuation)

    The duration of mechanical ventilation.

  4. Adverse Events Incidence

    Time frame: Completion of evacuation (expected day 2 of evacuation)

    The incidence of adverse events associated with nitric oxide treatment.

  5. Complication Rate

    Time frame: Completion of evacuation (expected day 2 of evacuation)

    The complication rate, specifically focusing on Grade 3-4 intraventricular hemorrhage, intraventricular plasmalacia, moderate to severe bronchopulmonary dysplasia, retinopathy of prematurity necessitating intervention, patent ductus arteriosus requiring either medical or surgical management, pulmonary hemorrhage, and air leak syndrome.

  6. ECMO Utilization Rate

    Time frame: Completion of evacuation (expected day 2 of evacuation)

    The proportion of cases that required extracorporeal membrane oxygenation (ECMO).

  7. Mortality Rate Before Discharge

    Time frame: Completion of evacuation (expected day 2 of evacuation)

    The mortality rate prior to discharge.

  8. Healthcare Utilization Preferences

    Time frame: Completion of evacuation (expected day 2 of evacuation)

    Scores obtained from questionnaires assessing preferences for healthcare utilization.The Likert Scale is used in the questionnaires to measure respondents' attitudes, preferences, or perceptions. It typically ranges from 1 to 5 points, where 1 represents "Strongly Disagree" and 5 represents "Strongly Agree". Respondents select the level that best reflects their opinion, allowing researchers to quantify subjective data and analyze trends effectively.

Study contacts

Contact information is provided by the study sponsor or research team.

Weiling Kong

CONTACT

[email protected]

+8613547827448

Zhicheng Zhu

CONTACT

[email protected]

+86 13601911685

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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