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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-03

Study Completion Date

2025-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Hypertension of Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nitric Oxide

Inhaled Nitric Oxide

Nitric Oxide Generator and Delivery System

Intervention Type DEVICE

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

Interventions

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Nitric Oxide Generator and Delivery System

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

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No