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NCT Number: NCT04898114

Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe persistent pulmonary hypertension on mechanical ventilation.

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Key information

Conditions

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

Location status: Recruiting

Location contact

Mostafa Abo-Sidera, MD, PhD

CONTACT

[email protected]

1002028668 ext. 0020

About this study

Persistent pulmonary hypertension of newborn (PPHN) is a serious condition that results from failure of the normal postnatal circulatory transition and is associated with significant mortality and morbidity. Advanced medical treatment, such as inhaled nitric oxide (iNO), high-frequency ventilation (HFV), and extracorporeal membrane oxygenation (ECMO) are commonly not available in developing countries. Intravenous magnesium sulfate has been shown to alleviate pulmonary hypertension but is associated with systemic hypotension and is less effective compared with iNO and sildenafil. Nebulized magnesium sulfate has been reported to be more effective and safer compared with intravenous magnesium sulfate in treating neonates with PPHN on mechanical ventilation. Combined nebulized magnesium and sildenafil has been studied in a small trial on spontaneously breathing neonates with PPHN but not on those connected to mechanical ventilation.

The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe PPHN on mechanical ventilation. We hypothesize that neonates with severe PPHN connected to mechanical ventilation could benefit from taking continuous nebulization of magnesium sulfate combined besides sildenafil.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gestational age ≥ 36 weeks
  • Birth weight between 2.5 and 4 kg.
  • Post-natal age between 6 and 72 hours.
  • PPHN confirmed by echocardiography
  • Oxygenation index (OI) > 30 on two occasions at least 15 minutes apart
  • Connected to Mechanical Ventilation

Exclusion criteria

  • Failure to obtain informed consent
  • Newborns to mothers who received magnesium sulfate within 48 hours before labor.
  • Congenital heart diseases, other than patent ductus arteriosus 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.
  • Prior administration of pulmonary vasodilators.
  • Gastrointestinal intolerance or bleeding

Treatment and study plan

Magnesium sulfate

Drug

Nebulized magnesium sulfate (4 ml of 6.4% solution) every 15 minutes

Other names: MgSO4

sildenafil citrate

Drug

Oral sildenafil citrate at an initial dose of 1 mg/kg, with incremental increases by 0.5 mg/kg every 6 hours till reaching a target dose of 2mg/kg every 6 hours.

Other names: Viagra

Isotonic saline

Other

Nebulized isotonic saline (4 ml) every 15 minutes

Other names: 0.9% NaCl

Primary outcomes

  1. Change in Oxygenation index (OI)

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

    OI will be calculated using the following formula: OI = [(FiO2 × MAP) / PaO2] (FiO2, fraction of inspired oxygen expressed in %; MAP, mean airway pressure in cmH2O/mmHg; and PaO2, partial pressure of arterial oxygen in mmHg).

Secondary outcomes

  1. Change in Mean arterial blood pressure (MABP)

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

  2. Change in Vasoactive Inotropic Score (VIS)

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

    The VIS will be calculated using the following 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).

  3. Change in Pulmonary artery systolic pressure (PASP)

    Time frame: From baseline to 24 hours after study drug administration

    PASP will be estimated by echocardiography using the modified Bernoulli equation: PASP = (TRJV2 × 4) + RAP (TRJV, tricuspid regurgitation jet velocity; RAP, right atrial pressure).

  4. Change in Serum magnesium level

    Time frame: From baseline to 24 hours after study drug administration

Study contacts

Contact information is provided by the study sponsor or research team.

Elsayed Abdelkreem, MD, PhD

CONTACT

[email protected]

00201114232126

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 24, 2021
Registry last updated
Nov 27, 2024

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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