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

Alexandria University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Persistent Pulmonary Hypertension of the Newborn Echocardiography Respiratory Disease

Interventions

Nebulized nitroglycerine as adjunctive therapyDRUG

Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy

conventional therapy for PPHNDRUG

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

Eligibility

Sex: ALLMin age: 1 HourMax age: 7 Days

Medical Language ↔ Plain English

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

Locations (1)

Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: first 7 days of life

Data from ClinicalTrials.gov

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