Treatment of Persistent Pulmonary Hypertension in Neonates With Nebulized Magnesium Sulfate (PPHN)

February 4, 2025 updated by: Heba Morsy Saad El Din El Ganady, Benha University

Comparative Study Between Nebuliezed and Intravenous Magnesium Sulfate for Treatment of Persistant Pulmonary Hypertension in Neonates

we conducted this study to compare between effect of nebulized and intravenous magnesium sulfate (MgSO₄) for better treatment of persistent pulmonary hypertension of neonates with less side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Persistent pulmonary hypertension of the newborn (PPHN) is a serious syndrome characterized by sustained fetal elevation of pulmonary vascular resistance (PVR) at birth. The syndrome is seen in two of 1000 live-born infants and is associated with anormal or low systemic vascular resistance. Pulmonary hypertension is defined as a mean pulmonary artery pressure greater than 25 mmHg at rest and > 30 mmHg during exercise. PPHN-targeted therapy is used for infants with PPHN who fail to respond to general cardiopulmonary supportive care. Oxygen and inhaled Nitric Oxide (iNO) are the only well-studied pulmonary vasodilators in neonates with PPHN. Magnesium is a potent vasodilator and hence has the potential to reduce the high pulmonary arterial pressures as it's able to dilate constricted muscles in the pulmonary arteries. However, its action is not specific and when given via an intravenous infusion, it will act on other muscles in the body including other arteries. Excessive magnesium causes hypotonia, hypotension, and cardiorespiratory failure. However, no studies have demonstrated long-term benefit. Delivering magnesium sulfate by nebulization may enhance effectiveness and minimizes systemic adverse effects.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Benha, Egypt., Egypt
        • Pediatrics Department, Faculty of Medicine, Benha University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newborns with documented persistent pulmonary hypertension as confirmed by echocardiography.
  • Neonates born at ≥ 35 wk. gestation with a birth weight of 2.5-4 kg
  • Neonates have to be connected to mechanical ventilation with an oxygenation index (OI) >30 on two occasions at least 15 min apart.
  • The echocardiogram had to show a predominant right-to-left or bidirectional shunt (through ductus arteriosus and/or foramen oval) and/or tricuspid regurgitant jet with a pressure gradient ≥ 2/3 of the systemic systolic blood pressure.

Exclusion Criteria:

  • Infants of parents who refuse to give informed consent.
  • Infants of mothers who receive magnesium sulfate within 48 h before labor.
  • Congenital heart diseases other than patent ductus arteriosus (PDA) and foramen ovale.
  • Major congenital anomalies, including congenital diaphragmatic hernia and lung hypoplasia.
  • Prior need for cardiopulmonary resuscitation
  • Mean arterial blood pressure (MABP) < 35 mmHg despite therapy with volume infusions and vasoactive inotropes.
  • Impaired kidney function; and prior administration of pulmonary vasodilators or prior administration of surfactant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nebulized magnesium (NebMag) group 1
NebMag group (n=20) was administered nebulized isotonic magnesium (64 mg/mL). For nebulization, an isotonic MgSO₄ solution (64 mg/mL) was formulated by diluting a 10% intravenous preparation of MgSO₄ heptahydrate with sterile distilled water. 4 mL aliquots of the isotonic MgSO₄ solution (containing 256 mg of MgSO₄) were administered every 15 minutes through the jet nebulizer connected to the ventilator during the 24 hour study period.
Drug: Inhalational magnesium sulfate
It gives us the same mechanism of action as IV MgSO4 with less side effects.
Other Names:
  • Inhalational MgSO4
Active Comparator: Intravenous magnesium (IVMag) group 2
IVMag group (n=20) received intravenous magnesium. For intravenous administration, a 10% MgSO₄ solution was prepared by diluting a 50% intravenous formulation of MgSO₄ heptahydrate with 5% glucose and administrated in a loading dose of 2 mL/kg over 30 minutes (equivalent to 200 mg/kg of MgSO₄), followed by a continuous infusion at a rate of 0.5 mL/kg/h (equivalent to 50 mg/kg/h of MgSO₄) over the 24 hour study period.
Drug: IV Magnesium Sulfate
MgSO₄'s mechanism in PPHN includes activating cellular processes, modulating membrane excitability, and acting as a physiological calcium antagonist. It exerts sedative, muscle relaxant, and bronchodilatory properties, while concurrently inducing a state of alkalosis.
Other Names:
  • IV MgSO4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Airway Pressure (cm H2O)
Time Frame: from baseline to 12 and 24 hours after administering the study drug
from baseline to 12 and 24 hours after administering the study drug
Fraction of Inspired Oxygen (FiO2) (%)
Time Frame: from baseline to 12 and 24 hours after administering the study drug
from baseline to 12 and 24 hours after administering the study drug
PaO2 (mmHg)
Time Frame: from baseline to 6, 12 and 24 hours after administering the study drug
kPa x 7.5 converts to the equivalent PaO2 in mmHg
from baseline to 6, 12 and 24 hours after administering the study drug
Tracking Changes in the Oxygenation Index (OI)
Time Frame: from baseline to 12 and 24 hours after administering the study drug

OI evaluates both oxygenation and ventilatory support, aiding decisions on Extracorporeal Membrane Oxygenation (ECMO) necessity in newborns with PPHN. OI calculated as (Mean Airway Pressure (cm H2O) x Fraction of Inspired Oxygen (%) x 100) ÷ (PaO2 (kPa) x 7.5).

OI is routinely used as an indicator of severity of hypoxemic respiratory failure (HRF) in neonates, with an arbitrary cutoff of 15 or less for mild HRF, between 16 and 25 for moderate HRF, between 26 and 40 for severe HRF, and more than 40 for very severe HRF
from baseline to 12 and 24 hours after administering the study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Variations in Mean Arterial Blood Pressure (MABP)
Time Frame: at 0, 12, and 24 hours post administration of the study drug relative to baseline
Both systolic and diastolic pressure are used to calculate MABP.
at 0, 12, and 24 hours post administration of the study drug relative to baseline
the Alterations in Serum Magnesium Levels (mmol/L)
Time Frame: from baseline to 12 hours following the administration of the study drug.
from baseline to 12 hours following the administration of the study drug.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Study Director: Osama Z. El Feky, Professor, Pediatrics Department, Faculty of Medicine, Benha University, Benha, Egypt.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

September 28, 2023

Study Completion (Actual)

September 28, 2023

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39-9-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

demographic data, preliminary clinical data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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