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Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

NCT04898114 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-27

No results posted yet for this study

Summary

The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe persistent pulmonary hypertension on mechanical ventilation.

Conditions

  • Persistent Pulmonary Hypertension of Newborn

Interventions

DRUG

Magnesium sulfate

Nebulized magnesium sulfate (4 ml of 6.4% solution) every 15 minutes

DRUG

Sildenafil Citrate

Oral sildenafil citrate at an initial dose of 1 mg/kg, with incremental increases by 0.5 mg/kg every 6 hours till reaching a target dose of 2mg/kg every 6 hours.

OTHER

Isotonic saline

Nebulized isotonic saline (4 ml) every 15 minutes

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • Elsayed Abdelkreem, MD, PhD · Sohag University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2025-04-30
Completion
2025-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898114 on ClinicalTrials.gov