Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

Persistent Pulmonary Hypertension of the Newborn Clinical Trial

— NebMag  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328636
• Other study ID #: NebMag-PPHN Study
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 1, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Persistent Fetal Circulation
• Persistent Fetal Circulation Syndrome
• Persistent Pulmonary Hypertension of the Newborn
• PPHN

Intervention

Drug:
• Nebulized Magnesium Sulfate
Nebulized magnesium sulfate (isotonic solution) 256 mg every 15 minutes
• 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

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Unit, Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean arterial blood pressure (MABP)	Changes in mean arterial blood pressure	At baseline to 2, 6, 12, and 24 hours following study drug administration.
Secondary	Serum magnesium level	Changes in serum magnesium level	At baseline to 12 hours after study drug adminstration
Secondary	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