Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia

Sponsor
Asan Medical Center
Study ID
NCT07247240
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Congenital Diaphragmatic Hernia
  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
1 Minute - 14 Days
Healthy Volunteers
Not accepted

Interventions

  • Inhaled Nitric Oxide — DRUG
    Inhalation of nitric oxide for 30 minutes in CDH approaching predefined criteria of moderate to severe pulmonary hypertension and define the short-term response

Study Details

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.

Key Dates

First listed
Nov 25, 2025
Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Inhaled Nitric Oxide
    Administration of inhaled NO in newborn infants with CDH approaching predefined criteria of pulmonary hypertension and hypoxic respiratory failure

Primary Outcome Measure

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

Central Contacts

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