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NCT Number: NCT05703191

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

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.

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Key information

Conditions

Pulmonary Hypertension of Newborn

Sex eligibility

All sexes

Study type

Observational

Primary location

ZhuJiang Hospital of Southern Medical University

Guangzhou, China

Location status: Recruiting

Location contact

Bin Wang

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitric Oxide Generator and Delivery System

Device

Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.

Primary outcomes

  1. Change From Baseline in Oxygenation Index (OI)

    Time frame: Baseline, Minutes 45

    OI = Mean Airway Pressure (MPAW)×100×Fraction of Inspiration Oxygen (FiO2)/Partial Pressure of Oxygen (PaO2)

Secondary outcomes

  1. Change From Baseline in Oxygenation Index (OI)

    Time frame: Baseline, Hour 24, 2 hours after iNO is discontinued

    OI = MPAW×100×FiO2/PaO2

  2. Change From Baseline in Oxygen Saturation

    Time frame: Baseline, Hour 24, 2 hours after iNO is discontinued

    Oxygen Saturation: Peripheral Capillary Oxygen Saturation (SpO2)

  3. Change From Baseline in Pulmonary Artery Pressure (PAP)

    Time frame: Baseline, Hour 24, 2 hours after iNO is discontinued

    Doppler echocardiography is used to detect the regurgitation velocity, and tricuspid regurgitation V values are derived. PAP = 4 × V2 + 5 mmHg.

  4. Percentage of subjects responding to iNO

    Time frame: Hour 24, 2 hours after iNO is discontinued

    Responding to iNO is defined as a decrease in OI of 25% or more

  5. 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

    Parameters detected by Nitric Oxide Generator and Delivery System

  6. Adverse events

    Time frame: Baseline up to 24 hours after iNO is discontinued

    Incidence of adverse events=Number of subjects with adverse events/Total number of subjects in treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Zhou Fang

CONTACT

[email protected]

+8615655595707

Sponsors and collaborators

Lead sponsor

Novlead Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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