Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

Sohag University28 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Persistent Fetal Circulation Persistent Pulmonary Hypertension of the Newborn PPHN

Interventions

Nebulized Magnesium SulfateDRUG

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

Intravenous Magnesium SulfateDRUG

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

Eligibility

Sex: ALLMin age: 6 HoursMax age: 72 Hours

Medical Language ↔ Plain English

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.

Locations (1)

Neonatal Intensive Care Unit, Sohag University Hospital

Sohag, Egypt

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Mean arterial blood pressure (MABP)

Changes in mean arterial blood pressure

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

Serum magnesium level

Changes in serum magnesium level

Time frame: 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)

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

Data from ClinicalTrials.gov

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