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Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn (NebMag)

Primary Purpose

Persistent Fetal Circulation, Persistent Pulmonary Hypertension of the Newborn, PPHN

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Nebulized Magnesium Sulfate

Intravenous Magnesium Sulfate

About this trial

This is an interventional treatment trial for Persistent Fetal Circulation focused on measuring neonate, persistent fetal circulation, persistent pulmonary hypertension of the newborn, PPHN, Magnesium Sulfate, Nebulizer, hypoxia

Eligibility Criteria

6 Hours - 72 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Newborns with PPHN fulfilling the following:

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

Exclusion Criteria:

failure to obtain informed consent.
infants of mothers who received magnesium sulfate within 48 hours before labor.
congenital heart diseases (other than PDA 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 inotrpic support.
impaired kidney function.
prior administration of pulmonary vasodilators.

Sites / Locations

Neonatal Intensive Care Unit, Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NebMag

IVMag

Arm Description

Neonates with PPHN receiving nebulized magnesium sulfate and intravenous placebo

Neonates with PPHN receiving intravenous magnesium sulfate and nebulized placebo

Outcomes

Primary Outcome Measures

Oxygenation index (OI)

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

Secondary Outcome Measures

Mean arterial blood pressure (MABP)

Changes in mean arterial blood pressure

Serum magnesium level

Changes in serum magnesium level

Vasoactive Inotropic Score (VIS)

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)

Full Information

NCT ID

NCT04328636

First Posted

March 29, 2020

Last Updated

August 14, 2020

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT04328636

Brief Title

Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

Acronym

NebMag

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

July 1, 2020 (Actual)

Study Completion Date

August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Persistent Fetal Circulation, Persistent Pulmonary Hypertension of the Newborn, PPHN

Keywords

neonate, persistent fetal circulation, persistent pulmonary hypertension of the newborn, PPHN, Magnesium Sulfate, Nebulizer, hypoxia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Two groups of neonates with PPHN NebMag group: receive nebulized magnesium sulfate and intravenous placebo. IVMag group: receive intravenous magnesium sulfate and nebulized placebo.

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

Each neonate was assigned a unique identification number. Pharmacy filled the active and placebo preparations in similar containers with sealed code for identification. Participants' families, treating clinicians, nurses, echocardiographers, and data collectors were unaware of group assignment and drug/placebo therapy.

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NebMag

Arm Type

Experimental

Arm Description

Neonates with PPHN receiving nebulized magnesium sulfate and intravenous placebo

Arm Title

IVMag

Arm Type

Active Comparator

Arm Description

Neonates with PPHN receiving intravenous magnesium sulfate and nebulized placebo

Intervention Type

Drug

Intervention Name(s)

Nebulized Magnesium Sulfate

Intervention Description

Nebulized magnesium sulfate (isotonic solution) 256 mg every 15 minutes

Intervention Type

Drug

Intervention Name(s)

Intravenous Magnesium Sulfate

Intervention Description

Intravenous magnesium sulfate 200 mg/kg over 30 minutes, followed by a continuous infusion at a rate of 50 mg/kg/hour

Primary Outcome Measure Information:

Title

Oxygenation index (OI)

Description

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

Time Frame

At baseline to 2, 6, 12, and 24 hours following study drug administration.

Secondary Outcome Measure Information:

Title

Mean arterial blood pressure (MABP)

Description

Changes in mean arterial blood pressure

Time Frame

At baseline to 2, 6, 12, and 24 hours following study drug administration.

Title

Serum magnesium level

Description

Changes in serum magnesium level

Time Frame

At baseline to 12 hours after study drug adminstration

Title

Vasoactive Inotropic Score (VIS)

Description

Time Frame

At baseline to 2, 6, 12, and 24 hours following study drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Hours

Maximum Age & Unit of Time

72 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Newborns with PPHN fulfilling the following: born at ≥ 37 weeks gestational age. birth weight between 2.5 and 4 kg. post-natal age between 6 and 72 hours. connected to mechanical ventilation with an oxygenation index (OI) > 30 on two occasions at least 15 minutes apart. documented PPHN confirmed by echocardiography. Exclusion Criteria: failure to obtain informed consent. infants of mothers who received magnesium sulfate within 48 hours before labor. congenital heart diseases (other than PDA 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 inotrpic support. impaired kidney function. prior administration of pulmonary vasodilators.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elsayed Abdelkreem, MD, PhD

Organizational Affiliation

Faculty of Medicine, Sohag University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neonatal Intensive Care Unit, Sohag University Hospital

City

Sohag

ZIP/Postal Code

82524

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

33415555

Citation

Abdelkreem E, Mahmoud SM, Aboelez MO, Abd El Aal M. Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of Newborn: A Pilot Randomized Controlled Trial. Indian J Pediatr. 2021 Aug;88(8):771-777. doi: 10.1007/s12098-020-03643-y. Epub 2021 Jan 8.

Results Reference

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Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

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