Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

Phase 1

Completed

• Conditions: Persistent Fetal Circulation; Persistent Pulmonary Hypertension of the Newborn; PPHN
• Interventions: Drug: Nebulized Magnesium Sulfate; Drug: Intravenous Magnesium Sulfate

• Registration Number: NCT04328636
• Lead Sponsor: Sohag University

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.

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 Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2020-03-29
• Study First Submitted QC: 2020-03-29
• Study First Posted: 2020-03-31
• Primary Completion: 2020-07-01
• Status Verified: 2020-08
• Study Completion: 2020-08-01
• Last Update Submitted: 2020-08-14
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NebMag	Nebulized Magnesium Sulfate	Neonates with PPHN receiving nebulized magnesium sulfate and intravenous placebo
IVMag	Intravenous Magnesium Sulfate	Neonates with PPHN receiving intravenous magnesium sulfate and nebulized placebo

Primary Outcome Measures

Name	Time	Method
Oxygenation index (OI)	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

Name	Time	Method
Mean arterial blood pressure (MABP)	At baseline to 2, 6, 12, and 24 hours following study drug administration.	Changes in mean arterial blood pressure
Serum magnesium level	At baseline to 12 hours after study drug adminstration	Changes in serum magnesium level
Vasoactive Inotropic Score (VIS)	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)

Trial Locations

Locations (1)

Neonatal Intensive Care Unit, Sohag University Hospital; 🇪🇬 Sohag, Egypt