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

Alexandria University

Status: Completed

Conditions: Respiratory Disease; Echocardiography; Persistent Pulmonary Hypertension of the Newborn

Treatments: Drug: Nebulized nitroglycerine as adjunctive therapy; Drug: conventional therapy for PPHN

Study type: Interventional

Funder types: Other

Identifiers

NCT05741229

0201737

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 1 hour to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Group I (nebulized nitroglycerine)

Active Comparator group

Description:

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

Treatment:

Drug: Nebulized nitroglycerine as adjunctive therapy

Group II (conentional treatment group)

Placebo Comparator group

Description:

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

Treatment:

Drug: conventional therapy for PPHN