NCT07247240

Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 1 Minute – 14 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Diaphragmatic Hernia
• Pulmonary Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

4 sites across 1 country: South Korea