Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

November 26, 2024 updated by: Elsayed Abdelkreem, Sohag University

Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Persistent pulmonary hypertension of newborn (PPHN) is a serious condition that results from failure of the normal postnatal circulatory transition and is associated with significant mortality and morbidity. Advanced medical treatment, such as inhaled nitric oxide (iNO), high-frequency ventilation (HFV), and extracorporeal membrane oxygenation (ECMO) are commonly not available in developing countries. Intravenous magnesium sulfate has been shown to alleviate pulmonary hypertension but is associated with systemic hypotension and is less effective compared with iNO and sildenafil. Nebulized magnesium sulfate has been reported to be more effective and safer compared with intravenous magnesium sulfate in treating neonates with PPHN on mechanical ventilation. Combined nebulized magnesium and sildenafil has been studied in a small trial on spontaneously breathing neonates with PPHN but not on those connected to mechanical ventilation.

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 PPHN on mechanical ventilation. We hypothesize that neonates with severe PPHN connected to mechanical ventilation could benefit from taking continuous nebulization of magnesium sulfate combined besides sildenafil.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Recruiting
        • Neonatal Intensive Care Unit, Sohag University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 hours to 3 days (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gestational age ≥ 36 weeks
  • Birth weight between 2.5 and 4 kg.
  • Post-natal age between 6 and 72 hours.
  • PPHN confirmed by echocardiography
  • Oxygenation index (OI) > 30 on two occasions at least 15 minutes apart
  • Connected to Mechanical Ventilation

Exclusion Criteria:

  • Failure to obtain informed consent
  • Newborns to mothers who received magnesium sulfate within 48 hours before labor.
  • Congenital heart diseases, other than patent ductus arteriosus and foramen ovale.
  • Major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia).
  • Prior need for cardiopulmonary resuscitation.
  • Mean arterial blood pressure (MABP) < 35 mmHg despite therapy with volume infusions and vasoactive inotropes.
  • Impaired kidney function.
  • Prior administration of pulmonary vasodilators.
  • Gastrointestinal intolerance or bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NebMag
Nebulized magnesium sulfate and oral sildenafil
Drug: Magnesium sulfate
Nebulized magnesium sulfate (4 ml of 6.4% solution) every 15 minutes
Other Names:
  • MgSO4
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 Names:
  • Viagra
Placebo Comparator: Control
Nebulized placebo (isotonic saline) and oral sildenafil
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 Names:
  • Viagra
Other: Isotonic saline
Nebulized isotonic saline (4 ml) every 15 minutes
Other Names:
  • 0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxygenation index (OI)
Time Frame: From baseline to 2, 6, 12, and 24 hours following study drug administration
OI will be calculated using the following formula: OI = [(FiO2 × MAP) / PaO2] (FiO2, fraction of inspired oxygen expressed in %; MAP, mean airway pressure in cmH2O/mmHg; and PaO2, partial pressure of arterial oxygen in mmHg).
From baseline to 2, 6, 12, and 24 hours following study drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean arterial blood pressure (MABP)
Time Frame: From baseline to 2, 6, 12, and 24 hours following study drug administration.
From baseline to 2, 6, 12, and 24 hours following study drug administration.
Change in Vasoactive Inotropic Score (VIS)
Time Frame: From baseline to 2, 6, 12, and 24 hours following study drug administration.
The VIS will be calculated using the following formula: VIS = dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 × epinephrine dose (µg/kg/min) + 100 × norepinephrine dose (µg/kg/min) + 10 × milrinone dose (µg/kg/min) + 10,000 × vasopressin dose (U/kg/min).
From baseline to 2, 6, 12, and 24 hours following study drug administration.
Change in Pulmonary artery systolic pressure (PASP)
Time Frame: From baseline to 24 hours after study drug administration
PASP will be estimated by echocardiography using the modified Bernoulli equation: PASP = (TRJV2 × 4) + RAP (TRJV, tricuspid regurgitation jet velocity; RAP, right atrial pressure).
From baseline to 24 hours after study drug administration
Change in Serum magnesium level
Time Frame: From baseline to 24 hours after study drug administration
From baseline to 24 hours after study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Elsayed Abdelkreem, MD, PhD, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neb-Mag-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Unidentified individual participant data will be available from the principal investigator upon reasonable request

IPD Sharing Time Frame

Three years after publication of the study results

IPD Sharing Access Criteria

Unidentified individual participant data can be requested from the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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