Congenital Diaphragmatic Hernia, Pulmonary Hypertension
Conditions
Keywords
Congenital Diaphragmatic Hernia, Nitric Oxide, 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.
Interventions
DRUGInhaled 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
Sponsors
Seoul National University Hospital
Severance Hospital
Chungnam National University Hospital
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Assessment of Clinical Response After Administration of Inhaled Nitric Oxide in cases of CDH with Early Pulmonary Hypertension
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 14 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to inhaled nitric oxide | 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. |
Countries
South Korea
Contacts
Primary ContactByong Sop Lee, MD, PhD
Backup ContactEuiseok Jung, MD, PhD
Outcome results
None listed