Close Loop Smart Weaning for INO With PPHN

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help newborns with Persistent Pulmonary Hypertension (PPHN) safely reduce their use of inhaled nitric oxide (iNO), a treatment that can help improve their breathing. The study will test an innovative device that automatically lowers the amount of iNO given to babies, which could make the process smoother and easier for both the infants and the healthcare team. This is important because current methods rely on manual adjustments by doctors and nurses, which can vary and may not always be the best for each patient.

To be eligible for this trial, infants must have started receiving iNO for at least 24 hours and shown a positive response to the treatment. Their guardians must understand the risks and benefits of the study and agree to participate. The trial is not yet recruiting participants, but once it starts, families can expect to be part of a process that aims to improve how weaning off iNO is done, potentially leading to better outcomes for their babies. It’s worth noting that the safety and effectiveness of this new approach need to be confirmed through this research before it can be widely used.

Gender

ALL

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.