Trial · NCT06603766
Treatment of Persistent Pulmonary Hypertension in Neonates With Nebulized Magnesium Sulfate
NCT06603766, Phase 2, Phase 3, Completed, Benha University; results first posted 2025-02-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Persistent Pulmonary Hypertension in Neonates With Nebulized Magnesium Sulfate. Trials, record NCT06603766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06603766
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Persistent Pulmonary Hypertension in Neonates With Nebulized Magnesium Sulfate
- NCT number
- NCT06603766
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- Benha University
- Conditions
- Magnesium Sulfate - PPHN
- Interventions
- IV Magnesium Sulfate, Inhalational magnesium sulfate
- First posted
- 2024-09-19
- Last updated
- 2025-02-05
- Results first posted
- 2025-02-05
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Airway Pressure (cm H2O) | from baseline to 12 and 24 hours after administering the study drug | |
| Primary | Fraction of Inspired Oxygen (FiO2) (%) | from baseline to 12 and 24 hours after administering the study drug | |
| Primary | PaO2 (mmHg) | from baseline to 6, 12 and 24 hours after administering the study drug | kPa x 7.5 converts to the equivalent PaO2 in mmHg |
| Primary | Tracking Changes in the Oxygenation Index (OI) | 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 | the Variations in Mean Arterial Blood Pressure (MABP) | 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. |
| Secondary | the Alterations in Serum Magnesium Levels (mmol/L) | from baseline to 12 hours following the administration of the study drug. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Airway Pressure (cm H2O) | from baseline to 12 and 24 hours after administering the study drug | (cm H2O) | MEAN | |
| PRIMARY | Fraction of Inspired Oxygen (FiO2) (%) | from baseline to 12 and 24 hours after administering the study drug | percentage | MEAN | |
| PRIMARY | PaO2 (mmHg) | from baseline to 6, 12 and 24 hours after administering the study drug | (mmHg) | MEAN | |
| PRIMARY | Tracking Changes in the Oxygenation Index (OI) | from baseline to 12 and 24 hours after administering the study drug | index | MEAN | |
| SECONDARY | the Variations in Mean Arterial Blood Pressure (MABP) | at 0, 12, and 24 hours post administration of the study drug relative to baseline | mmHg | MEAN | |
| SECONDARY | the Alterations in Serum Magnesium Levels (mmol/L) | from baseline to 12 hours following the administration of the study drug. | (mmol/L) | MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Airway Pressure (cm H2O) | Nebulized Magnesium (NebMag) Group 1 | Baseline | 14.1 | Standard Deviation 1.29 | (cm H2O) |
| Mean Airway Pressure (cm H2O) | Intravenous Magnesium (IVMag) Group 2 | Baseline | 13.8 | Standard Deviation 1.18 | (cm H2O) |
| Mean Airway Pressure (cm H2O) | Nebulized Magnesium (NebMag) Group 1 | At 12h | 13.7 | Standard Deviation 1 | (cm H2O) |
| Mean Airway Pressure (cm H2O) | Intravenous Magnesium (IVMag) Group 2 | At 12h | 13.25 | Standard Deviation 0.9 | (cm H2O) |
| Mean Airway Pressure (cm H2O) | Nebulized Magnesium (NebMag) Group 1 | At 24h | 14 | Standard Deviation 1.27 | (cm H2O) |
| Mean Airway Pressure (cm H2O) | Intravenous Magnesium (IVMag) Group 2 | At 24h | 13.8 | Standard Deviation 1.24 | (cm H2O) |
| Fraction of Inspired Oxygen (FiO2) (%) | Nebulized Magnesium (NebMag) Group 1 | baseline | 100 | Standard Deviation 0 | percentage |
| Fraction of Inspired Oxygen (FiO2) (%) | Intravenous Magnesium (IVMag) Group 2 | baseline | 100 | Standard Deviation 0 | percentage |
| Fraction of Inspired Oxygen (FiO2) (%) | Nebulized Magnesium (NebMag) Group 1 | at 12h | 96.5 | Standard Deviation 5.8 | percentage |
| Fraction of Inspired Oxygen (FiO2) (%) | Intravenous Magnesium (IVMag) Group 2 | at 12h | 97.5 | Standard Deviation 4.4 | percentage |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nebulized Magnesium (NebMag) Group 1 | 20 | |
| Overall Study | STARTED | Intravenous Magnesium (IVMag) Group 2 | 20 | |
| Overall Study | COMPLETED | Nebulized Magnesium (NebMag) Group 1 | 20 | |
| Overall Study | COMPLETED | Intravenous Magnesium (IVMag) Group 2 | 20 | |
| Overall Study | NOT COMPLETED | Nebulized Magnesium (NebMag) Group 1 | 0 | |
| Overall Study | NOT COMPLETED | Intravenous Magnesium (IVMag) Group 2 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nebulized Magnesium (NebMag) Group 1 | 0 | 20 |
| Total, all-cause mortality | Intravenous Magnesium (IVMag) Group 2 | 0 | 20 |
| Total, other adverse events | Nebulized Magnesium (NebMag) Group 1 | 0 | 20 |
| Total, other adverse events | Intravenous Magnesium (IVMag) Group 2 | 0 | 20 |
| Total, serious adverse events | Nebulized Magnesium (NebMag) Group 1 | 0 | 20 |
| Total, serious adverse events | Intravenous Magnesium (IVMag) Group 2 | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nebulized Magnesium (NebMag) Group 1 vs Intravenous Magnesium (IVMag) Group 2: deaths from any cause | Trial comparisons |
| Nebulized Magnesium (NebMag) Group 1 vs Intravenous Magnesium (IVMag) Group 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06603766
GET https://conductscience.org/api/trials/v1/NCT06603766/results?page=2