Nebulized nitroglycerin for treating persistent pulmonary hypertension in newborns
The Effect Of Nebulizied Nitroglycerin As An Adjuvant Drug In Management Of Persistent Pulmonary Hypertension Of Newborns
NA · Alexandria University · NCT05741229
This study is testing if using nebulized nitroglycerin can help newborns with persistent pulmonary hypertension feel better when added to their usual treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 1 Hour to 7 Days |
| Sex | All |
| Sponsor | Alexandria University (other) |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT05741229 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of nebulized nitroglycerin as an additional treatment for infants with persistent pulmonary hypertension of the newborn (PPHN). It focuses on assessing various echocardiographic and clinical parameters, including biventricular function, pulmonary artery pressure, and oxygen saturation. The study aims to determine if this adjunctive therapy can improve outcomes compared to conventional treatments. Infants who meet specific criteria will be enrolled to assess the efficacy of this intervention.
Who should consider this trial
Good fit: Ideal candidates are infants aged 72 hours or younger, born at or after 37 weeks of gestation, who require high levels of oxygen and show signs of PPHN.
Not a fit: Patients diagnosed with PPHN after 72 hours or those requiring milrinone treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve respiratory and cardiac function in newborns suffering from PPHN.
How similar studies have performed: While the use of nebulized nitroglycerin in this context is relatively novel, similar approaches have shown promise in other studies addressing pulmonary hypertension.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants ≤72 hours' old, ≥37 weeks of gestation, ≥50% FiO2 need despite lung recruitment, abnormal oxygen saturation index or echocardiographic signs of PPHN will be enrolled in the trial. Exclusion Criteria: * • Diagnosis of PPHN discovered after more than 72 hours. * Failure of used medications and need to administrate milrinone
Where this trial is running
Alexandria
- Alexandria University — Alexandria, Egypt (RECRUITING)
Study contacts
- Principal investigator: Moataz Shawky Rezk, MD — Alexandria University
- Study coordinator: Marwa M Farag, PhD
- Email: d.marwa.farag@gmail.com
- Phone: 01288681788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Persistent Pulmonary Hypertension of the Newborn, Echocardiography, Respiratory Disease