Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia With Early Pulmonary Hypertension
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Asan Medical Center
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Response to inhaled nitric oxide
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Minute to 14 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Inhaled Nitric Oxide
Administration of inhaled NO in newborn infants with CDH approaching predefined criteria of pulmonary hypertension and hypoxic respiratory failure
Intervention: Inhaled Nitric Oxide (Drug)
Outcomes
Primary Outcomes
Response to inhaled nitric oxide
Time Frame: At 30-60 minutes after administration of inhaled nitric oxide.
Participants were categorized as responders if their oxygenation index or FiO2 improved by more than 20% from baseline after administration of inhaled nitric oxide for at least 30 minutes.
Secondary Outcomes
No secondary outcomes reported
Investigators
Byong Sop Lee
Professor, Department of Pediatrics
Asan Medical Center