The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For Persistent Pulmonary Hypertension Of Newborns
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group I (nebulized nitroglycerine) Patients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN |
Drug: Nebulized nitroglycerine as adjunctive therapy
Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy
|
| Placebo Comparator: Group II (conentional treatment group) Patients with PPHN and will be treated with conventional regimen for PPHN |
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.
|
Outcome Measures
Primary Outcome Measures
- Estimation of Pulmonary artery pressure (PAP) [first 7 days of life]
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.
- Right ventricular (RV) function in ml/kg/min [first 7 days of life]
• 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.
- Left ventricular (LV)function in ml/kg/min [first 7 days of life]
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.
Eligibility Criteria
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.
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Failure of used medications and need to administrate milrinone
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alexandria University
Investigators
- Study Chair: Hesham Ghazal, PhD, Alexandria University
- Study Director: Aly Mohamed Abdel-Mohsen, PhD, Alexandria University
- Principal Investigator: Moataz Shawky Rezk, MD, Alexandria University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0201737