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

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

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 Overview

• Status: Recruiting
• Conditions: Persistent Pulmonary Hypertension of the Newborn; Respiratory Disease; Echocardiography
• Intervention / Treatment: Drug: Nebulized nitroglycerine as adjunctive therapy; Drug: conventional therapy for PPHN

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa M Farag, PhD; Phone Number: +2 01288681788; Email: d.marwa.farag@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt, 0325
    • Recruiting
    • Alexandria University
    • Contact: Marwa M Farag; Phone Number: 01288681788; Email: d.marwa.farag@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 week (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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.	first 7 days of life

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): August 20, 2024
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Lung Diseases; Infant, Newborn, Diseases; Hypertension; Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome; Respiration Disorders; Respiratory Tract Diseases; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: 0201737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No