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

Asan Medical Center

Status and phase: Not yet enrolling; Phase 4

Conditions: Pulmonary Hypertension; Congenital Diaphragmatic Hernia

Treatments: Drug: Inhaled Nitric Oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT07247240

INOCDH_2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 minute to 14 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Inhaled Nitric Oxide

Experimental group

Description:

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

Treatment:

Drug: Inhaled Nitric Oxide