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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-01-20

Brief Summary

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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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Detailed Description

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Conditions

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Persistent Pulmonary Hypertension of the Newborn Echocardiography Respiratory Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I (nebulized nitroglycerine)

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

Group Type ACTIVE_COMPARATOR

Nebulized nitroglycerine as adjunctive therapy

Intervention Type DRUG

Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy

Group II (conentional treatment group)

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

Group Type PLACEBO_COMPARATOR

conventional therapy for PPHN

Intervention Type DRUG

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

Interventions

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Nebulized nitroglycerine as adjunctive therapy

Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.