Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Nebulized Magnesium Sulfate
* Drug: Intravenous Magnesium Sulfate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Hours
Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | Changes in mean arterial blood pressure | At baseline to 2, 6, 12, and 24 hours following study drug administration. | 
| Serum magnesium level | Changes in serum magnesium level | At baseline to 12 hours after study drug adminstration | 
| 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) | At baseline to 2, 6, 12, and 24 hours following study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonate, persistent fetal circulation, persistent pulmonary hypertension of the newborn, PPHN, Magnesium Sulfate, Nebulizer, hypoxia