Closed-loop smart weaning of inhaled nitric oxide for newborns with PPHN

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Neonates with PPHN who have received or are expected to receive inhaled nitric oxide (iNO) for 24 hours or more and who show a positive response will be enrolled. The intervention uses an intelligent closed-loop iNO delivery system that automatically adjusts dosing to achieve a gradual wean, compared with current manual stepwise weaning managed by clinical staff. Primary outcomes include duration and stability of the weaning process, safety endpoints such as rebound pulmonary hypertension, and measures of clinician workload and variability. The goal is to create a standardized, evidence-based weaning pathway that reduces subjective decision-making and bedside burden.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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);
2. There is a demonstrable positive response to iNO treatment;
3. The iNO delivery system employed is appropriate and meets the conditional requirements, featuring an intelligent closed-loop offline functionality;
4. 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:

1. There are established contraindications associated with the use of nitric oxide, which include the following conditions:

   1. Severe hypoplasia of the left heart or duct-dependent congenital heart disease;
   2. Life-threatening congenital anomalies and congestive heart failure;
   3. Congenital methemoglobinemia;
   4. Significant hemorrhagic events, such as intracranial hemorrhage, intraventricular hemorrhage, and pulmonary hemorrhage.
2. 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.
3. 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.
4. 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.
5. Participation in concurrent clinical trials involving other pharmacological agents or medical devices is prohibited.
6. The investigator may determine that participation in this study is not appropriate for certain individuals.

Where it's running

• Children's Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Lin Yuan — Children's Hospital of Fudan University
• Study coordinator: Zhicheng Zhu
• Email: jonney116@sina.com
• Phone: +86 13601911685

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.