Study on the Use of Inhaled NO (iNO) (POSITIVE)

Air Liquide

Status: Completed

Conditions: Pulmonary Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT02821156

ALMED-13-C4-046

Details and patient eligibility

About

This is a prospective, observational, multicenter study conducted during 1 year in adult and paediatric intensive care units equipped with the EZ-KINOX™ system.

A maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial Hypertension (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™ system was planned to be included.

The study is strictly non-interventional with the aim of describing current practices and therefore did not affect the patient usual management.

Full description

This study is intended to describe daily practice and therefore, there is not a standardized protocol but only patient-based and site-based questionnaires.

Enrollment: 239 patients

Sex: All

Ages: 1+ day old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborn > or = to 34 weeks gestational age suffering from hypoxic respiratory failure with pulmonary hypertension (France only) or patient presenting post-operative pulmonary hypertension associated with cardiac surgery (France and Belgium) · Patient treated with iNO delivered with EZ-KINOX™

Exclusion criteria

• Newborn dependent on a right-to-left shunt or with a "malignant" left-right arterial canal
• Newborn with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.