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Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia

ConditionsCongenital Diaphragmatic HerniaPulmonary Hypertension
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Inhaled Nitric OxideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Response to 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.

Time frame
At 30-60 minutes after administration of inhaled nitric oxide.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

Seoul National University Hospital

Collaborator

Severance Hospital

Collaborator

Chungnam National University Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: