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Completed

NCT Number: NCT06603766

Treatment of Persistent Pulmonary Hypertension in Neonates With Nebulized Magnesium Sulfate

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.

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Key information

Age range

1 hour–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pediatrics Department, Faculty of Medicine, Benha University.

Benha, Egypt., Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

IV Magnesium Sulfate

Drug

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

Inhalational magnesium sulfate

Drug

It gives us the same mechanism of action as IV MgSO4 with less side effects.

Other names: Inhalational MgSO4

Primary outcomes

  1. Mean Airway Pressure (cm H2O)

    Time frame: from baseline to 12 and 24 hours after administering the study drug

  2. Fraction of Inspired Oxygen (FiO2) (%)

    Time frame: from baseline to 12 and 24 hours after administering the study drug

  3. 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

  4. 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

Secondary outcomes

  1. 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.

  2. the Alterations in Serum Magnesium Levels (mmol/L)

    Time frame: from baseline to 12 hours following the administration of the study drug.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: PPHN

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Feb 5, 2025

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.