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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect Of Nebulizied Nitroglycerin As An Adjuvant Drug In Management Of Persistent Pulmonary Hypertension Of Newborns

Conditions
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Persistent Pulmonary Hypertension of the Newborn, Echocardiography, Respiratory Disease

Intervention / Treatment
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* Drug: Nebulized nitroglycerine as adjunctive therapy
* Drug: conventional therapy for PPHN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (nebulized nitroglycerine)<br>Patients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN | Drug: Nebulized nitroglycerine as adjunctive therapy<br>* Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy<br>|
| Placebo Comparator: Group II (conentional treatment group)<br>Patients with PPHN and will be treated with conventional regimen for PPHN | Drug: conventional therapy for PPHN<br>* patients will receive sildenafil which is used routinely in management of PPHN in our unit, in addition to appropriate oxygenation and ventilation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. The estimation of SPAP by measuring TR is reliable and often equivalent to pressures measured in the catheter lab while using continuous wave Doppler. However, the accuracy depends on the quality of the acquired TR jet. An optimal quality TR jet shows a well demarcated envelope. Right atrial pressure (RAP) is usually not measured, and a value of 3- 5 mmHg is generally assumed. | first 7 days of life | 
| Right ventricular (RV) function in ml/kg/min | • RV output and stroke distance in main pulmonary artery: CSA (cm) (Cross sectional area of PV by long axis parasternal RV outflow view - 2D - immediately beneath pulmonary annulus - mid-systole - inner edge to inner edge) = π x (radius)2 ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Long axis parasternal RV outflow view). 12. ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). Output (L/min.) COP = SV x HR. | first 7 days of life | 
| Left ventricular (LV)function in ml/kg/min | LV output and stroke distance in ascending aorta: CSA (cm) (Cross sectional area of AV by long axis parasternal view - 2D - immediately beneath aortic annulus - mid- systole - inner edge to inner edge) = π x (radius)2. ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Apical 5-chamber view). SV (ml/beat) (Stroke Volume = CSA x VTI). Output (L/min.) COP = SV x HR. | first 7 days of life |