Congenital Diaphragmatic HerniaPhase 4INOCDHNCT07247240
Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia
A Phase 4 study testing Inhaled Nitric Oxide in people with Congenital Diaphragmatic Hernia and Pulmonary Hypertension, run by Asan Medical Center at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 14 days
- Conditions the study is for
- Congenital Diaphragmatic Hernia, Pulmonary Hypertension
- What is being tested?
- Inhaled Nitric Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Nov 2025to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Bochdalek type congenital diaphragmatic hernia
- Gestational age at 34 weeks or more and within 14 days after birth
- Hypoxic respiratory failure and pulmonary hypertension
Who cannot join
- Combined congenital heart disease requiring neonatal intervention or surgery
- Previous treatment of pulmonary vasodilators including inhaled nitric oxide
- on ECMO treatment
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites
Chonnam National University Hospital
Gwangju, 44935
Eun-Song Song, MD, 82-2-2206646, dab-77@hanmail.net
Asan Medical Center
Seoul, Seoul, 05505
Byong Sop Lee, MD, PhD, 82-2-3010-3929, mdleebs@amc.seoul.kr
Byong Sop Lee, MD, PhD
Seoul National University Children's Hospital
Seoul, 03080
Seung Han Shin, MD, PhD, 82-2-1588-5700, revival421@snu.ac.kr
Severance Hospital
Seoul, 03722
Ho Sun Eun, MD, 82-2-2228-5966, HSEUN@yuhs.ac.kr
About this study
Official title: Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia With Early Pulmonary Hypertension
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.
Read the 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.
- Being tested
- Inhaled Nitric Oxide
- Keywords
- Congenital Diaphragmatic Hernia, Nitric Oxide, Pulmonary Hypertension
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Nitric OxideDrug
Also called iNO, Nitric Oxide gas
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 group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide | Experimental | Administration of inhaled NO in newborn infants with CDH approaching predefined criteria of pulmonary hypertension and hypoxic respiratory failure Receives: Drug: Inhaled Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 30-60 minutes after administration of inhaled nitric oxide.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Assessment of Clinical Response After Administration of Inhaled Nitric Oxide in cases of CDH with Early Pulmonary Hypertension
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Severance Hospital, Chungnam National University Hospital
- Responsible party
- Principal investigator, Byong Sop Lee, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247240
- Sponsor's protocol ID
- INOCDH_2025
- Acronym
- INOCDH
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia With Early Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07247240
- Acronym / sponsor ID
- INOCDH / INOCDH_2025
- Keywords
- Congenital Diaphragmatic Hernia, Nitric Oxide, Pulmonary Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Severance Hospital, Chungnam National University Hospital
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assessment of Clinical Response After Administration of Inhaled Nitric Oxide in cases of CDH with Early Pulmonary Hypertension
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxide | Experimental | Drug: Inhaled Nitric OxideAdministration of inhaled NO in newborn infants with CDH approaching predefined criteria of pulmonary hypertension and hypoxic respiratory failure |
Who may qualify
- Ages
- 1 minute to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Bochdalek type congenital diaphragmatic hernia
- Gestational age at 34 weeks or more and within 14 days after birth
- Hypoxic respiratory failure and pulmonary hypertension
Key exclusion criteria (3 listed)
- Combined congenital heart disease requiring neonatal intervention or surgery
- Previous treatment of pulmonary vasodilators including inhaled nitric oxide
- on ECMO treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled Nitric OxideAlso: iNO, Nitric Oxide gasInhalation of nitric oxide for 30 minutes in CDH approaching predefined criteria of moderate to severe pulmonary hypertension and define the short-term response | Drug | Inhaled Nitric Oxide |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Diaphragmatic Hernia
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
Congenital Diaphragmatic Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inhaled Nitric Oxide in people with Congenital Diaphragmatic Hernia and Pulmonary Hypertension, run by Asan Medical Center at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Byong Sop Lee, MD, PhD (82-2-3010-3929, mdleebs@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to inhaled nitric oxide (time frame: At 30-60 minutes after administration of inhaled nitric oxide.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.