Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn (NebMag)

Sohag University

Status and phase: Completed; Phase 2; Phase 1

Conditions: PPHN; Persistent Pulmonary Hypertension of the Newborn; Persistent Fetal Circulation

Treatments: Drug: Intravenous Magnesium Sulfate; Drug: Nebulized Magnesium Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04328636

NebMag-PPHN Study

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 6 to 72 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups

NebMag

Experimental group

Description:

Neonates with PPHN receiving nebulized magnesium sulfate and intravenous placebo

Treatment:

Drug: Nebulized Magnesium Sulfate

IVMag

Active Comparator group

Description:

Neonates with PPHN receiving intravenous magnesium sulfate and nebulized placebo

Treatment:

Drug: Intravenous Magnesium Sulfate