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Completed

NCT Number: NCT04328636

Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

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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Key information

Conditions

Persistent Fetal Circulation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypertension, Pulmonary Hypoxia Infant, Newborn, Diseases Lung Diseases PPHN Pathological Conditions, Signs and Symptoms Persistent Fetal Circulation Syndrome Persistent Pulmonary Hypertension of the Newborn Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

6 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Neonatal Intensive Care Unit, Sohag University Hospital

Sohag, 82524, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newborns with PPHN fulfilling the following:

  • born at ≥ 37 weeks gestational age.
  • birth weight between 2.5 and 4 kg.
  • post-natal age between 6 and 72 hours.
  • connected to mechanical ventilation with an oxygenation index (OI) > 30 on two occasions at least 15 minutes apart.
  • documented PPHN confirmed by echocardiography.

Exclusion criteria

  • failure to obtain informed consent.
  • infants of mothers who received magnesium sulfate within 48 hours before labor.
  • congenital heart diseases (other than 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 inotrpic support.
  • impaired kidney function.
  • prior administration of pulmonary vasodilators.

Treatment and study plan

Nebulized Magnesium sulfate

Drug

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

Intravenous magnesium sulfate

Drug

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

Primary outcomes

  1. Oxygenation index (OI)

    Time frame: 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 outcomes

  1. Mean arterial blood pressure (MABP)

    Time frame: At baseline to 2, 6, 12, and 24 hours following study drug administration.

    Changes in mean arterial blood pressure

  2. Serum magnesium level

    Time frame: At baseline to 12 hours after study drug adminstration

    Changes in serum magnesium level

  3. Vasoactive Inotropic Score (VIS)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Acronym: NebMag

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2020
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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