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Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn (NebMag)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328636
Recruitment Status : Completed
First Posted : March 31, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Elsayed Abdelkreem, Sohag University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Persistent Fetal Circulation Persistent Pulmonary Hypertension of the Newborn PPHN Drug: Nebulized Magnesium Sulfate Drug: Intravenous Magnesium Sulfate Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two groups of neonates with PPHN

  1. NebMag group: receive nebulized magnesium sulfate and intravenous placebo.
  2. IVMag group: receive intravenous magnesium sulfate and nebulized placebo.
Masking: Triple (Participant, Care Provider, Outcomes 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.
Primary Purpose: Treatment
Official Title: Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of The Newborn
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : August 1, 2020

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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

  2. Serum magnesium level [ Time Frame: At baseline to 12 hours after study drug adminstration ]
    Changes in serum magnesium level

  3. 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)



Eligibility Criteria
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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04328636


Locations
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Egypt
Neonatal Intensive Care Unit, Sohag University Hospital
Sohag, Egypt, 82524
Sponsors and Collaborators
Sohag University
Investigators
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Principal Investigator: Elsayed Abdelkreem, MD, PhD Faculty of Medicine, Sohag University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Elsayed Abdelkreem, Lecturer of Pediatrics, Sohag University
ClinicalTrials.gov Identifier: NCT04328636    
Other Study ID Numbers: NebMag-PPHN Study
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020

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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
Keywords provided by Elsayed Abdelkreem, Sohag University:
neonate
persistent fetal circulation
persistent pulmonary hypertension of the newborn
PPHN
 Magnesium Sulfate
Nebulizer
hypoxia
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents