Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn (NebMag)

August 14, 2020 updated by: Elsayed Abdelkreem, Sohag University

Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of The Newborn

The aim of this pilot randomized controlled blinded study is to evaluate the feasibility of using nebulized magnesium sulfate in the treatment of PPHN.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effectiveness and safety of nebulized magnesium sulfate (using isotonic solution in a dose of 1024 mg/hour) is compared with intravenous magnesium sulfate (200 mg/kg over 30 minutes, followed by 50 mg/kg/hour) in treating mechanically ventilated neonates with severe persistent pulmonary hypertension of the newborn.

Study Type

Interventional

Enrollment (Actual)

28

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 Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Neonatal Intensive Care Unit, Sohag University Hospital

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Newborns with PPHN fulfilling the following:

  1. born at ≥ 37 weeks gestational age.
  2. birth weight between 2.5 and 4 kg.
  3. post-natal age between 6 and 72 hours.
  4. connected to mechanical ventilation with an oxygenation index (OI) > 30 on two occasions at least 15 minutes apart.
  5. documented PPHN confirmed by echocardiography.

Exclusion Criteria:

  1. failure to obtain informed consent.
  2. infants of mothers who received magnesium sulfate within 48 hours before labor.
  3. congenital heart diseases (other than PDA and foramen ovale).
  4. major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia).
  5. prior need for cardiopulmonary resuscitation.
  6. mean arterial blood pressure (MABP) < 35 mmHg despite therapy with volume infusions and inotrpic support.
  7. impaired kidney function.
  8. prior administration of pulmonary vasodilators.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NebMag
Neonates with PPHN receiving nebulized magnesium sulfate and intravenous placebo
Drug: Nebulized Magnesium Sulfate
Nebulized magnesium sulfate (isotonic solution) 256 mg every 15 minutes
Active Comparator: IVMag
Neonates with PPHN receiving intravenous magnesium sulfate and nebulized placebo
Drug: Intravenous Magnesium Sulfate
Intravenous magnesium sulfate 200 mg/kg over 30 minutes, followed by a continuous infusion at a rate of 50 mg/kg/hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation index (OI)
Time Frame: At baseline to 2, 6, 12, and 24 hours following study drug administration.

Change in oxygenation index (OI) calculated by the classic formula:

OI = [(FiO2 * MAP) / PaO2]

FiO2 expressed in %; MAP in cmH2O/mmHg; and PaO2 in mmHg
At baseline to 2, 6, 12, and 24 hours following study drug administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial blood pressure (MABP)
Time Frame: At baseline to 2, 6, 12, and 24 hours following study drug administration.
Changes in mean arterial blood pressure
At baseline to 2, 6, 12, and 24 hours following study drug administration.
Serum magnesium level
Time Frame: At baseline to 12 hours after study drug adminstration
Changes in serum magnesium level
At baseline to 12 hours after study drug adminstration
Vasoactive Inotropic Score (VIS)
Time Frame: At baseline to 2, 6, 12, and 24 hours following study drug administration

Changes in VIS calculated by the classic 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)
At baseline to 2, 6, 12, and 24 hours following 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, Faculty of Medicine, 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)

November 1, 2017

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

March 29, 2020

First Submitted That Met QC Criteria

March 29, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NebMag-PPHN Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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