Echocardiography, Persistent Pulmonary Hypertension of the Newborn, Respiratory Disease
Conditions
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.
Interventions
DRUGNebulized nitroglycerine as adjunctive therapy
Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy
DRUGconventional 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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 7 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed