A Real-world Study of Nitric Oxide Generator and Delivery System

Novlead

Status: Enrolling

Conditions: Pulmonary Hypertension of Newborn

Treatments: Device: Nitric Oxide Generator and Delivery System

Study type: Observational

Funder types: Industry

Identifiers

NCT05703191

PAH22-09

Details and patient eligibility

About

The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings.

Enrollment: 10 estimated patients

Sex: All

Ages: 34+ weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians
2. Admitted to the Department of Neonatology at the hospital, gender unlimited
3. Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
4. Documented Oxygenation index (OI) ≥8 prior to the treatment
5. Signed informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this study

Exclusion criteria

1. Proven risks of nitric oxide contraindication
2. Undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation
3. Other circumstances that investigators believe unsuitable for enrollment

Trial design

10 participants in 1 patient group

Nitric Oxide

Description:

Inhaled Nitric Oxide

Treatment:

Device: Nitric Oxide Generator and Delivery System