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Completed

NCT Number: NCT05741229

The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For 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.

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Key information

Conditions

Persistent Pulmonary Hypertension of the Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Echocardiography Hypertension, Pulmonary Infant, Newborn, Diseases Lung Diseases Persistent Fetal Circulation Syndrome Respiration Disorders Respiratory Disease Respiratory Tract Diseases

Age range

1 hour–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University

Alexandria, 0325, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nebulized nitroglycerine as adjunctive therapy

Drug

Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy

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.

Primary outcomes

  1. Estimation of Pulmonary artery pressure (PAP)

    Time frame: 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.

  2. Right ventricular (RV) function in ml/kg/min

    Time frame: 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.

  3. Left ventricular (LV)function in ml/kg/min

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 23, 2023
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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