Stopping routine inhaled nitric oxide during newborn stabilization for congenital diaphragmatic hernia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter stepped-wedge cluster-randomized study, participating centers will follow their usual inhaled nitric oxide (iNO) protocols and then crossover at randomized times to de-implement iNO during the immediate postnatal resuscitation/stabilization period. The primary outcome is a composite of ECLS use and/or mortality, with secondary analyses of ECLS, mortality, oxygenation, and an economic analysis of incremental health system costs per prevented ECLS use or death. Eligible patients are live-born neonates with Bochdalek CDH diagnosed within the first month of life who are born at or transferred to a participating center within one week. Outcomes will be compared across clusters before and after de-implementation to determine clinical and cost effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Postnatal, live born neonates with CDH

  a. Presence of associated or additional anomalies is acceptable for inclusion
* Bochdalek hernia location (right or left)
* Diagnosed prior to 1 month of life
* Born within or transferred to (within 1 week of life) a CDHSG member center participating in the trial

Exclusion Criteria:

* CDH diagnosis after 1 month of age
* Morgagni diaphragmatic hernia (central / anterior-medial diaphragmatic defect location)
* Transferred to a CDH Study Group (CDHSG) member center after 1 week of life
* Patients without potential access to iNO

Where it's running

• University of Alabama & Children's Hospital of Alabama (UAB-CoA)
  Birmingham, Alabama, United States Recruiting
• University of Arkansas & Arkansas Children's Hospital (UA-ACH)
  Little Rock, Arkansas, United States Recruiting
• University of California-Irvine & Children's Hospital of Orange County (UC-CHOC)
  Irvine, California, United States Recruiting
• University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
  Los Angeles, California, United States Recruiting
• Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH)
  Palo Alto, California, United States Recruiting
• University of California, San Diego & Rady Children's Hospital (UCSD-Rady)
  San Diego, California, United States Recruiting

Study contacts

• Principal investigator: Matthew Harting, MD, MS, FACS — The University of Texas Health Science Center, Houston
• Study coordinator: Matthew Harting, MD, MS, FACS
• Email: Matthew.T.Harting@uth.tmc.edu
• Phone: (713) 500-7398

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Melatonin plus inhaled nitric oxide for pulmonary hypertension in full-term newborns

  This study tests whether adding melatonin to inhaled nitric oxide helps treat pulmonary hypertension in full-term neonates.

  Recruiting Ain Shams University · Cairo, Abbassia · NCT07850934

• FETO with a Goldballoon device for fetuses with diaphragmatic hernia

  This study tests whether performing Fetoscopic Endoluminal Tracheal Occlusion on pregnancies with fetal diaphragmatic hernia improves baby survival and reduces long-term problems.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07577414

• Fetal tracheal occlusion (FETO) for severe congenital diaphragmatic hernia

  This trial will test whether fetal endoluminal tracheal occlusion (FETO) helps fetuses with severe congenital diaphragmatic hernia and intrathoracic liver herniation survive to hospital discharge.

  Recruiting Phase 3 Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07187206

• Long-term outcomes after FETO for severe left or right congenital diaphragmatic hernia

  This trial will test whether performing FETO in fetuses with isolated severe left or right CDH helps more babies survive to hospital discharge and have fewer long-term problems than standard care.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT07166172

• Fetal treatment for congenital diaphragmatic hernia

  This study is testing a new way to treat congenital diaphragmatic hernia in unborn babies by placing a balloon in their airway to help their lungs grow before they are born.

  Recruiting Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT06884423

• Fetoscopic balloon (FETO) for severe left and right congenital diaphragmatic hernia — long-term outcomes

  This trial will try placing and later removing a tiny balloon in the fetal windpipe around 27–29 weeks to help babies with severe congenital diaphragmatic hernia and liver herniation survive the newborn period.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT06739356

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.