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ClinicalTrials.gov ID

NCT07247240

Lead Sponsor

Asan Medical CenterOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

40Estimated

Last Update Posted

Nov 25, 2025Actual

Start Date

Nov 2025Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2028Estimated

Official Title

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

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.

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.

• Congenital Diaphragmatic Hernia
• Pulmonary Hypertension

• Inhaled Nitric Oxide

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Asan Medical CenterOTHER

Collaborators

Seoul National University HospitalOTHER

Severance HospitalOTHER

Chungnam National University HospitalOTHER

HSEUN@yuhs.ac.kr82-2-2228-5966