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Clinical Trials in South Korea / NCT07247240
Starting soon Phase 4

Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia

NCT07247240 · tracked via the Priya Life Science South Korea tracker
Sponsor
Asan Medical Center
Phase
Phase 4
Started
2025-11
Last updated
2025-11-25

Condition(s) studied

Congenital Diaphragmatic HerniaPulmonary Hypertension

Investigational drug(s) / intervention(s)

Inhaled Nitric Oxide →

Inhaled Nitric Oxide: Inhalation of nitric oxide for 30 minutes in CDH approaching predefined criteria of moderate to severe pulmonary hypertension and define the short-term response

Study summary

This multicenter, prospective, single-arm study aims to evaluate the efficacy of inhaled nitric oxide (iNO) in neonates with congenital diaphragmatic hernia (CDH) and early pulmonary hypertension. Short-term treatment response will be assessed by the changes in oxygenation index and other parameters including echocardiographic parameters at predefined intervals.

Eligibility

Sex
ALL
Min age
1 Minute
Max age
14 Days
Healthy volunteers
No
Inclusion Criteria: * Bochdalek type congenital diaphragmatic hernia * Gestational age at 34 weeks or more and within 14 days after birth * Hypoxic respiratory failure and pulmonary hypertension Exclusion Criteria: * Combined congenital heart disease requiring neonatal intervention or surgery * Previous treatment of pulmonary vasodilators including inhaled nitric oxide * on ECMO treatment

Primary outcome measure(s)

  • Response to inhaled nitric oxide — At 30-60 minutes after administration of inhaled nitric oxide.
    Participants were categorized as responders if their oxygenation index or FiO2 improved by more than 20% from baseline after administration of inhaled nitric oxide for at least 30 minutes.

Trial sites (4)

FacilityCityRegionStatus
Asan Medical Center Seoul Seoul
Chonnam National University Hospital Gwangju South Korea
Seoul National University Children's Hospital Seoul South Korea
Severance Hospital Seoul South Korea

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Other trials for the same condition

A Study of Mosliciguat in PH-ILD Active, not recruiting
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) Recruiting
A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489 Active, not recruiting
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Enrolling by invitation
Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07247240 on ClinicalTrials.gov ↗ ← All trials in South Korea