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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized magnesium (NebMag) group 1 | Active Comparator | 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. |
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| Intravenous magnesium (IVMag) group 2 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Airway Pressure (cm H2O) | from baseline to 12 and 24 hours after administering the study drug | |
| Fraction of Inspired Oxygen (FiO2) (%) | from baseline to 12 and 24 hours after administering the study drug | |
| PaO2 (mmHg) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the Variations in Mean Arterial Blood Pressure (MABP) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osama Z. El Feky, Professor | Pediatrics Department, Faculty of Medicine, Benha University, Benha, Egypt. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatrics Department, Faculty of Medicine, Benha University. | Benha, Egypt. | Egypt |
demographic data, preliminary clinical data
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The total number of neonates who admitted at Benha University hospital diagnosed as PPHN during study period was 158. 95 was excluded as they did not meet inclusion criteria. 23 parents refused to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Inhalational magnesium sulfate: It gives us the same mechanism of action as IV MgSO4 with less side effects. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Inhalational magnesium sulfate: It gives us the same mechanism of action as IV MgSO4 with less side effects. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Airway Pressure (cm H2O) | Posted | Mean | Standard Deviation | (cm H2O) | from baseline to 12 and 24 hours after administering the study drug |
|
this study couldn't detect adverse event during 24 h study duration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Inhalational magnesium sulfate: It gives us the same mechanism of action as IV MgSO4 with less side effects. |
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First, the study involved a limited group of neonates with PPHN. Second, a single dosage of magnesium was administered via continuous nebulization in this trial. It is still technically difficult to have a reliable & effective nebulization system while using mechanical breathing. Thirdly, effects of nebulized magnesium sulfate in combination with other pulmonary vasodilators were not disclosed by study. Finally, because of study's constrained time frame, critical outcomes could not be addressed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heba Morsy Saad El Din El Ganady | faculty of medicine Benha University | +201111211367 | Heba.Aljanadi21@fmed.bu.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2025 | Feb 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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|
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| Inhalational magnesium sulfate | Drug | It gives us the same mechanism of action as IV MgSO4 with less side effects. |
|
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| from baseline to 12 hours following the administration of the study drug. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| gestional weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight (kg) | Mean | Standard Deviation | kg |
|
| mode of delivery | Count of Participants | Participants |
|
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.
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.
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| Primary | Fraction of Inspired Oxygen (FiO2) (%) | Posted | Mean | Standard Deviation | percentage | from baseline to 12 and 24 hours after administering the study drug |
|
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| Primary | PaO2 (mmHg) | kPa x 7.5 converts to the equivalent PaO2 in mmHg | Posted | Mean | Standard Deviation | (mmHg) | from baseline to 6, 12 and 24 hours after administering the study drug |
|
|
|
|
| Primary | Tracking Changes in the Oxygenation Index (OI) | 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 | Posted | Mean | Standard Deviation | index | from baseline to 12 and 24 hours after administering the study drug |
|
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| Secondary | the Variations in Mean Arterial Blood Pressure (MABP) | Both systolic and diastolic pressure are used to calculate MABP. | Posted | Mean | Standard Deviation | mmHg | at 0, 12, and 24 hours post administration of the study drug relative to baseline |
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| Secondary | the Alterations in Serum Magnesium Levels (mmol/L) | Posted | Mean | Standard Deviation | (mmol/L) | from baseline to 12 hours following the administration of the study drug. |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| at 24h |
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| 24H |
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| 24h |
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| 24h |
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