Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-14
SponsorAsan Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Bochdalek type congenital diaphragmatic hernia
Gestational age at 34 weeks or more and within 14 days after birth
Hypoxic respiratory failure and pulmonary hypertension
Disqualifiers
Combined congenital heart disease requiring neonatal intervention or surgery
Previous treatment of pulmonary vasodilators including inhaled nitric oxide
on ECMO treatment
Trial design
Treatments tested in this trial
- Inhaled Nitric Oxide
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
4Asan Medical Center05505, SeoulSeoul, South Korea
Chonnam National University Hospital44935, Gwangju South Korea
Seoul National University Children's Hospital03080, Seoul South Korea
Severance Hospital03722, Seoul South Korea
Sponsors and collaborators
Asan Medical Center
Lead sponsor
Seoul National University Hospital
Collaborator
Severance Hospital
Collaborator
Chungnam National University Hospital
Collaborator
Source ClinicalTrials.gov