Inhaled Nitric Oxide for Diaphragmatic Hernia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how inhaled nitric oxide (iNO) affects newborns with congenital diaphragmatic hernia (CDH). Researchers aim to determine if stopping iNO during the first days after birth impacts survival rates and the need for additional medical support, such as ECLS (a heart-lung machine). They also assess the cost-effectiveness of using or not using iNO. Eligible participants are babies diagnosed with CDH before one month old and treated at specific centers. As a Phase 4 trial, this research helps clarify how this FDA-approved and effective treatment benefits more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What is the safety track record for Inhaled Nitric Oxide (iNO)?
Research has shown that inhaled nitric oxide (iNO) is generally safe for newborns. However, its effectiveness and safety for specific conditions, such as congenital diaphragmatic hernia (CDH), remain under discussion. Some studies suggest that iNO might not be effective and could even be harmful for babies with CDH.
For example, one study found that iNO might assist babies with CDH who have high blood pressure in their lungs, but it did not provide clear guidance on which babies would benefit most. Another study raised safety concerns, suggesting potential negative effects.
In summary, while iNO is commonly used, opinions vary on its safety and effectiveness for CDH. It is important to consult healthcare providers to understand the potential risks and benefits before participating in a trial involving iNO.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about exploring the use of inhaled nitric oxide (iNO) for treating diaphragmatic hernia because it offers a targeted approach to managing pulmonary hypertension, a common complication of the condition. Unlike traditional methods that might involve mechanical ventilation or surgical interventions, iNO is administered directly as a gas that relaxes blood vessels in the lungs, potentially improving oxygenation quickly and effectively. This non-invasive method might reduce the need for more aggressive treatments and improve outcomes in newborns during the critical initial resuscitation period.
What evidence suggests that this trial's treatments could be effective for diaphragmatic hernia?
Research has shown that using inhaled nitric oxide (iNO) for babies with a diaphragmatic hernia yields mixed results. In this trial, one group of participants will receive iNO during their initial resuscitation period, while another group will not. Some studies indicate that many hospitals use iNO, but its effectiveness for these babies remains unclear. Data suggests that iNO does not consistently improve survival rates or reduce the need for additional life support, such as a heart-lung machine (ECLS). Despite its widespread use, evidence suggests that iNO might not always be beneficial and could sometimes even be harmful. This raises questions about its value in treating newborns with this condition.13678
Who Is on the Research Team?
Matthew T. Harting, MD, MS
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
This trial is for newborns with a type of hernia called Bochdalek, diagnosed before they turn one month old. They must be born at or transferred to a participating center within their first week of life. Babies without access to the tested treatment or diagnosed after one month, or those with Morgagni hernia are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Resuscitation and Stabilization
Centers use iNO per their usual protocol during the initial resuscitation period, which includes birth through stabilization and CDH repair
De-implementation
Centers stop using iNO in the initial resuscitation period as part of the de-implementation strategy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including ECLS use and/or mortality until hospital discharge
What Are the Treatments Tested in This Trial?
Interventions
- De-implementation of Inhaled Nitric Oxide (iNO) use
- Inhaled Nitric Oxide (iNO)
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor