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

Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741229
• Other study ID #: 0201737
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: August 20, 2024

Study information

• Verified date: January 2024
• Source: Alexandria University
• Contact: Marwa M Farag, PhD
• Phone: 01288681788
• Email: d.marwa.farag[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 20, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Echocardiography
• Hypertension
• Hypertension, Pulmonary
• Persistent Fetal Circulation Syndrome
• Persistent Pulmonary Hypertension of the Newborn
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Drug:
• Nebulized nitroglycerine as adjunctive therapy
Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy
• 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.

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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) = p 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
Primary	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) = p 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