Trial Outcomes & Findings for Treatment of Persistent Pulmonary Hypertension in Neonates With Nebulized Magnesium Sulfate (NCT NCT06603766)
NCT ID: NCT06603766
Last Updated: 2025-02-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
40 participants
Primary outcome timeframe
from baseline to 12 and 24 hours after administering the study drug
Results posted on
2025-02-05
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nebulized Magnesium (NebMag) Group 1
n=20 Participants
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.
|
Intravenous Magnesium (IVMag) Group 2
n=20 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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.1 gestional weeks
STANDARD_DEVIATION 0.9 • n=20 Participants
|
37.2 gestional weeks
STANDARD_DEVIATION 1.1 • n=20 Participants
|
37.15 gestional weeks
STANDARD_DEVIATION 1 • n=40 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Egypt
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
|
Body weight (kg)
|
3.1 kg
STANDARD_DEVIATION 0.3 • n=20 Participants
|
3.1 kg
STANDARD_DEVIATION 0.3 • n=20 Participants
|
3.1 kg
STANDARD_DEVIATION 0.3 • n=40 Participants
|
|
mode of delivery
vaginal delivery
|
7 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
mode of delivery
caesarean delivery
|
13 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: from baseline to 12 and 24 hours after administering the study drugOutcome measures
| Measure |
Nebulized Magnesium (NebMag) Group 1
n=20 Participants
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.
|
Intravenous Magnesium (IVMag) Group 2
n=20 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.
|
|---|---|---|
|
Mean Airway Pressure (cm H2O)
Baseline
|
14.1 (cm H2O)
Standard Deviation 1.29
|
13.8 (cm H2O)
Standard Deviation 1.18
|
|
Mean Airway Pressure (cm H2O)
At 12h
|
13.7 (cm H2O)
Standard Deviation 1
|
13.25 (cm H2O)
Standard Deviation 0.9
|
|
Mean Airway Pressure (cm H2O)
At 24h
|
14 (cm H2O)
Standard Deviation 1.27
|
13.8 (cm H2O)
Standard Deviation 1.24
|
PRIMARY outcome
Timeframe: from baseline to 12 and 24 hours after administering the study drugOutcome measures
| Measure |
Nebulized Magnesium (NebMag) Group 1
n=20 Participants
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.
|
Intravenous Magnesium (IVMag) Group 2
n=20 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.
|
|---|---|---|
|
Fraction of Inspired Oxygen (FiO2) (%)
baseline
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
|
Fraction of Inspired Oxygen (FiO2) (%)
at 12h
|
96.5 percentage
Standard Deviation 5.8
|
97.5 percentage
Standard Deviation 4.4
|
|
Fraction of Inspired Oxygen (FiO2) (%)
at 24h
|
96 percentage
Standard Deviation 5.9
|
97 percentage
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: from baseline to 6, 12 and 24 hours after administering the study drugkPa x 7.5 converts to the equivalent PaO2 in mmHg
Outcome measures
| Measure |
Nebulized Magnesium (NebMag) Group 1
n=20 Participants
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.
|
Intravenous Magnesium (IVMag) Group 2
n=20 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.
|
|---|---|---|
|
PaO2 (mmHg)
Baseline
|
38.45 (mmHg)
Standard Deviation 2
|
38.35 (mmHg)
Standard Deviation 1.63
|
|
PaO2 (mmHg)
12H
|
54.8 (mmHg)
Standard Deviation 5.43
|
51.45 (mmHg)
Standard Deviation 3.46
|
|
PaO2 (mmHg)
24H
|
69.45 (mmHg)
Standard Deviation 7.56
|
60.75 (mmHg)
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: from baseline to 12 and 24 hours after administering the study drugOI 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
Outcome measures
| Measure |
Nebulized Magnesium (NebMag) Group 1
n=20 Participants
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.
|
Intravenous Magnesium (IVMag) Group 2
n=20 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.
|
|---|---|---|
|
Tracking Changes in the Oxygenation Index (OI)
Baseline
|
34.3 index
Standard Deviation 2.4
|
34.1 index
Standard Deviation 2.2
|
|
Tracking Changes in the Oxygenation Index (OI)
12h
|
24.2 index
Standard Deviation 2.6
|
25.1 index
Standard Deviation 2.4
|
|
Tracking Changes in the Oxygenation Index (OI)
24h
|
19.75 index
Standard Deviation 2.9
|
22.1 index
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: at 0, 12, and 24 hours post administration of the study drug relative to baselineBoth systolic and diastolic pressure are used to calculate MABP.
Outcome measures
| Measure |
Nebulized Magnesium (NebMag) Group 1
n=20 Participants
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.
|
Intravenous Magnesium (IVMag) Group 2
n=20 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.
|
|---|---|---|
|
the Variations in Mean Arterial Blood Pressure (MABP)
Baseline
|
45.8 mmHg
Standard Deviation 2.7
|
45.7 mmHg
Standard Deviation 2.7
|
|
the Variations in Mean Arterial Blood Pressure (MABP)
12h
|
53.6 mmHg
Standard Deviation 3.2
|
48.6 mmHg
Standard Deviation 2.3
|
|
the Variations in Mean Arterial Blood Pressure (MABP)
24h
|
56.8 mmHg
Standard Deviation 3.3
|
53.6 mmHg
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: from baseline to 12 hours following the administration of the study drug.Outcome measures
| Measure |
Nebulized Magnesium (NebMag) Group 1
n=20 Participants
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.
|
Intravenous Magnesium (IVMag) Group 2
n=20 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.
|
|---|---|---|
|
the Alterations in Serum Magnesium Levels (mmol/L)
Baseline
|
0.92 (mmol/L)
Standard Deviation 0.1
|
0.93 (mmol/L)
Standard Deviation 0.1
|
|
the Alterations in Serum Magnesium Levels (mmol/L)
At 12h
|
1.2 (mmol/L)
Standard Deviation 0.17
|
3.6 (mmol/L)
Standard Deviation 0.18
|
Adverse Events
Nebulized Magnesium (NebMag) Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intravenous Magnesium (IVMag) Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Heba Morsy Saad El Din El Ganady
faculty of medicine Benha University
Phone: +201111211367
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place