Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-08-01

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.

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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.

Conditions

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Persistent Fetal Circulation Persistent Pulmonary Hypertension of the Newborn PPHN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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NebMag

Neonates with PPHN receiving nebulized magnesium sulfate and intravenous placebo

Group Type EXPERIMENTAL

Nebulized Magnesium Sulfate

Intervention Type DRUG

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

IVMag

Neonates with PPHN receiving intravenous magnesium sulfate and nebulized placebo

Group Type ACTIVE_COMPARATOR

Intravenous Magnesium Sulfate

Intervention Type DRUG

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

Interventions

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Nebulized Magnesium Sulfate

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No