Actively Recruiting

Phase 1
Phase 2
Age: 6Hours - 72Hours
All Genders
NCT04898114

Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

Led by Sohag University · Updated on 2024-11-27

40

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

Who Can Participate

Age: 6Hours - 72Hours
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age 236 weeks or more
  • Birth weight between 2.5 and 4 kilograms
  • Post-natal age between 6 and 72 hours
  • Diagnosis of persistent pulmonary hypertension of the newborn confirmed by echocardiography
  • Oxygenation index greater than 30 on two occasions at least 15 minutes apart
  • Currently connected to mechanical ventilation
Not Eligible

You will not qualify if you...

  • Inability to obtain informed consent
  • Newborns whose mothers received magnesium sulfate within 48 hours before labor
  • Presence of congenital heart diseases other than patent ductus arteriosus and foramen ovale
  • Major congenital anomalies, including congenital diaphragmatic hernia and lung hypoplasia
  • Previous need for cardiopulmonary resuscitation
  • Mean arterial blood pressure below 35 mmHg despite therapy
  • Impaired kidney function
  • Prior use of pulmonary vasodilators
  • Gastrointestinal intolerance or bleeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Neonatal Intensive Care Unit, Sohag University Hospital

Sohag, Egypt, 82524

Actively Recruiting

Loading map...

Research Team

E

Elsayed Abdelkreem, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here