Health TrialsbyHealthPanel

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

ConditionPulmonary Hypertension of Newborn
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNovlead Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Newborns

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Nitric Oxide Generator and Delivery System

    Device

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Nitric Oxide1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Oxygenation Index (OI)

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

Time frame
Baseline, Minutes 45

Secondary outcomes

1

Change From Baseline in Oxygenation Index (OI)

OI = MPAW×100×FiO2/PaO2

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

Change From Baseline in Oxygen Saturation

Oxygen Saturation: Peripheral Capillary Oxygen Saturation (SpO2)

Time frame
Baseline, Hour 24, 2 hours after iNO is discontinued
3

Change From Baseline in Pulmonary Artery Pressure (PAP)

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

Time frame
Baseline, Hour 24, 2 hours after iNO is discontinued
4

Percentage of subjects responding to iNO

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

Time frame
Hour 24, 2 hours after iNO is discontinued

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novlead Inc.

Lead sponsor

Source ClinicalTrials.gov
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