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Recruiting NCT05703191

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

— Observational Pulmonary Hypertension of Newborn

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nitric Oxide Generator and Delivery System.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension of Newborn. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study

Overview

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.

Interventions

  • Device Nitric Oxide Generator and Delivery System
    Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.

Primary outcome measures

  • Change From Baseline in Oxygenation Index (OI) [Time frame: Baseline, Minutes 45]
Secondary outcome measures (6)
  • Change From Baseline in Oxygenation Index (OI) [Time frame: Baseline, Hour 24, 2 hours after iNO is discontinued]
  • Change From Baseline in Oxygen Saturation [Time frame: Baseline, Hour 24, 2 hours after iNO is discontinued]
  • Change From Baseline in Pulmonary Artery Pressure (PAP) [Time frame: Baseline, Hour 24, 2 hours after iNO is discontinued]
  • Percentage of subjects responding to iNO [Time frame: Hour 24, 2 hours after iNO is discontinued]
  • Ventilation and monitoring parameters of Nitric Oxide Generator and Delivery System during treatment [Time frame: Minutes 45, Hour 24, 2 hours after iNO is discontinued]
  • Adverse events [Time frame: Baseline up to 24 hours after iNO is discontinued]

Eligibility criteria

Inclusion criteria

  • Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians
  • Admitted to the Department of Neonatology at the hospital, gender unlimited
  • Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
  • Documented Oxygenation index (OI) ≥8 prior to the treatment
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • ZhuJiang Hospital of Southern Medical University — Guangzhou

Identifiers

NCT: NCT05703191 · PAH22-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗