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

Not Applicable

Recruiting

• Conditions: Respiratory Disease; Persistent Pulmonary Hypertension of the Newborn; Echocardiography
• Interventions: Drug: Nebulized nitroglycerine as adjunctive therapy; Drug: conventional therapy for PPHN

• Registration Number: NCT05741229
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-07-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-04-20
• Study Completion: 2025-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (nebulized nitroglycerine)	Nebulized nitroglycerine as adjunctive therapy	Patients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN
Group II (conentional treatment group)	conventional therapy for PPHN	Patients with PPHN and will be treated with conventional regimen for PPHN

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt