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

NCT05741229 | Completed

• 1 other identifier: 0201737
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Pulmonary Hypertension of the Newborn; Echocardiography; Respiratory Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group I (nebulized nitroglycerine)

ACTIVE COMPARATOR

Patients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN

Drug: Nebulized nitroglycerine as adjunctive therapy

Group II (conentional treatment group)

PLACEBO COMPARATOR

Patients with PPHN and will be treated with conventional regimen for PPHN

Drug: conventional therapy for PPHN

Interventions

Nebulized nitroglycerine as adjunctive therapy DRUG

Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy

Group I (nebulized nitroglycerine)

conventional therapy for PPHN DRUG

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

Group II (conentional treatment group)

Eligibility Criteria

• Age: 1 Hour - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of PPHN discovered after more than 72 hours.
• Failure of used medications and need to administrate milrinone

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, 0325, Egypt

Location

Related Publications (2)

• Bethou A. Utility of Nebulized Magnesium Sulfate Therapy for Persistent Pulmonary Hypertension of Newborn. Indian J Pediatr. 2021 Aug;88(8):749-750. doi: 10.1007/s12098-021-03851-0. Epub 2021 Jun 23. No abstract available.

  PMID: 34164785 BACKGROUND

• Farag MM, Ghazal HAE, Abdel-Mohsen AM, Rezk MA. Nebulized nitroglycerin as an adjuvant drug in management of persistent pulmonary hypertension of newborns: a randomized controlled trial. Eur J Pediatr. 2025 Sep 1;184(9):586. doi: 10.1007/s00431-025-06381-5.

  PMID: 40888971 DERIVED

Related Links

• Idea about neubilized medications in PPHN

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome; Respiration Disorders

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hesham Ghazal, PhD

  Alexandria University

  STUDY CHAIR

• Aly Mohamed Abdel-Mohsen, PhD

  Alexandria University

  STUDY DIRECTOR

• Moataz Shawky Rezk, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: January 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 20, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 years after termination of study
• Access Criteria: available on reasonable request to researcher

Locations

EG (1)