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Not yet recruiting NCT07247240

Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia

Phase IV Interventional Congenital Diaphragmatic Hernia Pulmonary Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inhaled Nitric Oxide.
Who it may be relevant to
Registry conditions: Congenital Diaphragmatic Hernia, Pulmonary Hypertension. Basic parameters: 1 Minute — 14 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Response to inhaled nitric oxide [Time frame: At 30-60 minutes after administration of inhaled nitric oxide.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 4 centers
  • Asan Medical Center — Seoul
  • Chonnam National University Hospital — Gwangju
  • Seoul National University Children's Hospital — Seoul
  • Severance Hospital — Seoul

Identifiers

NCT: NCT07247240 · INOCDH_2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗