Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia (INOCDH)

Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia With Early Pulmonary Hypertension

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Hypertension; Congenital Diaphragmatic Hernia
• Intervention / Treatment: Drug: Inhaled Nitric Oxide

Detailed Description

Congenital diaphragmatic hernia (CDH) is a life-threatening congenital anomaly characterized by pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN). Despite advances in neonatal intensive care, management of pulmonary hypertension remains a major challenge, and the role of inhaled nitric oxide (iNO) in this population is still controversial.

This study evaluates the therapeutic efficacy and physiological responses to iNO in late preterm (34 weeks of gestational age or more) or term neonates with Bochdalek-type CDH and severe pulmonary hypertension who require mechanical ventilation but are not placed on ECMO within 14 days of life.

iNO will be initiated at 20 ppm, and serial measurements of oxygenation index, arterial blood gas, vital signs, cerebral oxygen saturation (NIRS), and echocardiographic indices will be performed to evaluate the short-term treatment response.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Byong Sop Lee, MD, PhD; Phone Number: 82-2-3010-3929; Email: mdleebs@amc.seoul.kr
• Study Contact Backup: Name: Euiseok Jung, MD, PhD; Phone Number: 82-2-3010-3372; Email: euisjung@amc.seoul.kr

Study Locations

• South Korea
  • Gwangju, South Korea, 44935
    • Chonnam National University Hospital
    • Contact: Eun-Song Song, MD; Phone Number: 82-2-2206646; Email: dab-77@hanmail.net
  • Seoul, South Korea, 03722
    • Severance Hospital
    • Contact: Ho Sun Eun, MD; Phone Number: 82-2-2228-5966; Email: HSEUN@yuhs.ac.kr
  • Seoul, South Korea, 03080
    • Seoul National University Children's Hospital
    • Contact: Seung Han Shin, MD, PhD; Phone Number: 82-2-1588-5700; Email: revival421@snu.ac.kr
  • Seoul
    • Seoul, Seoul, South Korea, 05505
      • Asan Medical Center
      • Contact: Byong Sop Lee, MD, PhD; Phone Number: 82-2-3010-3929; Email: mdleebs@amc.seoul.kr
      • Principal Investigator: Byong Sop Lee, MD, PhD
      • Sub-Investigator: Euiseok Jung, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inhaled Nitric Oxide; Administration of inhaled NO in newborn infants with CDH approaching predefined criteria of pulmonary hypertension and hypoxic respiratory failure	Drug: 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; Other Names: iNO, Nitric Oxide gas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Seoul National University Hospital; Severance Hospital; Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pulmonary Hypertension; Nitric Oxide; Congenital Diaphragmatic Hernia
• Additional Relevant MeSH Terms: Internal Hernia; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Respiratory Tract Diseases; Lung Diseases; Congenital Abnormalities; Hernia; Hernia, Diaphragmatic; Hypertension; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hypertension, Pulmonary; Hernias, Diaphragmatic, Congenital; Vasodilator Agents; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Purines; Nucleosides; Ribonucleosides; Purine Nucleosides; Cardiovascular Agents; Inosine; Endothelium-Dependent Relaxing Factors
• Other Study ID Numbers: INOCDH_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No