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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (nebulized nitroglycerine) | Active Comparator | Patients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN |
|
| Group II (conentional treatment group) | Placebo Comparator | Patients with PPHN and will be treated with conventional regimen for PPHN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulized nitroglycerine as adjunctive therapy | Drug | Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of Pulmonary artery pressure (PAP) | Systolic pulmonary artery pressure (SPAP) can be estimated by measuring the peak velocity of tricuspid valve regurgitation with the use of the modified Bernoulli's equation.
| first 7 days of life |
| Right ventricular (RV) function in ml/kg/min | • RV output and stroke distance in main pulmonary artery:
| first 7 days of life |
| Left ventricular (LV)function in ml/kg/min | LV output and stroke distance in ascending aorta:
| first 7 days of life |
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Inclusion Criteria:
Exclusion Criteria:
• Diagnosis of PPHN discovered after more than 72 hours.
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| Name | Affiliation | Role |
|---|---|---|
| Hesham Ghazal, PhD | Alexandria University | Study Chair |
| Aly Mohamed Abdel-Mohsen, PhD | Alexandria University | Study Director |
| Moataz Shawky Rezk, MD | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Alexandria | 0325 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34164785 | Background | Bethou A. Utility of Nebulized Magnesium Sulfate Therapy for Persistent Pulmonary Hypertension of Newborn. Indian J Pediatr. 2021 Aug;88(8):749-750. doi: 10.1007/s12098-021-03851-0. Epub 2021 Jun 23. No abstract available. | |
| 40888971 | Derived | Farag MM, Ghazal HAE, Abdel-Mohsen AM, Rezk MA. Nebulized nitroglycerin as an adjuvant drug in management of persistent pulmonary hypertension of newborns: a randomized controlled trial. Eur J Pediatr. 2025 Sep 1;184(9):586. doi: 10.1007/s00431-025-06381-5. |
| Label | URL |
|---|---|
| Idea about neubilized medications in PPHN | View source |
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Data is available for meta-analysis or any useful study upon reasonable request to authors
6 years after termination of study
available on reasonable request to researcher
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| conventional therapy for PPHN | Drug | patients will receive sildenafil which is used routinely in management of PPHN in our unit, in addition to appropriate oxygenation and ventilation. |
|
| ID | Term |
|---|---|
| D010547 | Persistent Fetal Circulation Syndrome |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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