Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia

NCT07247240 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: INOCDH_2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Congenital Diaphragmatic Hernia; Pulmonary Hypertension

Keywords

Congenital Diaphragmatic Hernia; Nitric Oxide; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Response to 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.

  At 30-60 minutes after administration of inhaled nitric oxide.

Study Arms (1)

Inhaled Nitric Oxide

EXPERIMENTAL

Administration of inhaled NO in newborn infants with CDH approaching predefined criteria of pulmonary hypertension and hypoxic respiratory failure

Drug: Inhaled Nitric Oxide

Interventions

Inhaled Nitric Oxide DRUG

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

Also known as: iNO, Nitric Oxide gas

Inhaled Nitric Oxide

Eligibility Criteria

• Age: 1 Minute - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Bochdalek type congenital diaphragmatic hernia
• Gestational age at 34 weeks or more and within 14 days after birth
• Hypoxic respiratory failure and pulmonary hypertension

You may not qualify if:

• Combined congenital heart disease requiring neonatal intervention or surgery
• Previous treatment of pulmonary vasodilators including inhaled nitric oxide
• on ECMO treatment

Sponsors & Collaborators

• Asan Medical Center: lead
• Seoul National University Hospital: collaborator
• Severance Hospital: collaborator
• Chungnam National University Hospital: collaborator

Study Sites (4)

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

Chonnam National University Hospital

Gwangju, 44935, South Korea

Location

Seoul National University Children's Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Hypertension, Pulmonary

Interventions

Inosine; Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Byong Sop Lee, MD, PhD

CONTACT

82-2-3010-3929; mdleebs@amc.seoul.kr

Euiseok Jung, MD, PhD

CONTACT

82-2-3010-3372; euisjung@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pediatrics

Model Details: Assessment of Clinical Response After Administration of Inhaled Nitric Oxide in cases of CDH with Early Pulmonary Hypertension

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 25, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

KR (4)