The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For Persistent Pulmonary Hypertension Of Newborns

Study Purpose

This aim of the study is to evaluate the effect of nebulized nitroglycerin on echocardiographic (biventricular function, pulmonary artery pressure, PDA and PFO shunting and tissue doppler imaging) and clinical parameters (Oxygen saturation index, heart rate, blood pressure, mean airway pressure, ventilation setting) in patients with PPHN.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Hour - 7 Days
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05741229
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Alexandria University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hesham Ghazal, PhDAly Mohamed Abdel-Mohsen, PhDMoataz Shawky Rezk, MD
Principal Investigator Affiliation	Alexandria UniversityAlexandria UniversityAlexandria University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Persistent Pulmonary Hypertension of the Newborn, Echocardiography, Respiratory Disease

Arms & Interventions

Arms

Active Comparator: Group I (nebulized nitroglycerine)

Patients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN

Placebo Comparator: Group II (conentional treatment group)

Patients with PPHN and will be treated with conventional regimen for PPHN

Interventions

Drug: - Nebulized nitroglycerine as adjunctive therapy

Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy

Drug: - conventional therapy for PPHN

patients will receive sildenafil which is used routinely in management of PPHN in our unit, in addition to appropriate oxygenation and ventilation.

Contact a Trial Team

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