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

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

We're testing an automated closed-loop system to wean inhaled nitric oxide in newborns with persistent pulmonary hypertension (PPHN) to see if it standardizes the process and reduces staff workload.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sex: All
• Sponsor: Children's Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06832163 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are newborns diagnosed with PPHN who have been started on or are expected to receive iNO for at least 24 hours, show a positive response to iNO, and whose guardian consents to participation.

Not a fit: Infants with established contraindications to nitric oxide (for example, severe left heart hypoplasia, duct-dependent congenital heart disease, or other life-threatening congenital anomalies), those who do not respond to iNO, or those requiring alternative advanced support may not benefit from the weaning system.

Why it matters

Potential benefit: If successful, the closed-loop system could shorten and standardize iNO weaning, reduce the risk of rebound pulmonary hypertension, and lower bedside staff workload.

How similar studies have performed: While automated closed-loop approaches have been applied to other neonatal respiratory supports with some positive results, closed-loop automated weaning specifically for inhaled nitric oxide remains relatively novel and not widely tested.

Eligibility criteria

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 this trial is running

Shanghai

• 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

Conditions Persistent Pulmonary Hypertension of the Newborn; Inhaled Nitric Oxide