Magnesium Sulfate - PPHNPhase 2/3PPHNNCT06603766
Treatment of Persistent Pulmonary Hypertension in Neonates With Nebulized Magnesium Sulfate
A Phase 2/3 study testing IV Magnesium Sulfate and Inhalational magnesium sulfate in people with Magnesium Sulfate - PPHN, run by Benha University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 hour to 3 days
- Conditions the study is for
- Magnesium Sulfate - PPHN
- What is being tested?
- IV Magnesium Sulfate and Inhalational magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 28 Sep 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatrics Department, Faculty of Medicine, Benha University.
Benha, Egypt.
About this study
Official title: Comparative Study Between Nebuliezed and Intravenous Magnesium Sulfate for Treatment of Persistant Pulmonary Hypertension in Neonates
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.
Read the detailed description
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.
- Conditions
- Magnesium Sulfate - PPHN
- Being tested
- IV Magnesium Sulfate, Inhalational magnesium sulfate
- Keywords
- PPHN, magnesium sulfate, Neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Magnesium SulfateDrug
Also called IV MgSO4
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.
Inhalational magnesium sulfateDrug
Also called Inhalational MgSO4
It gives us the same mechanism of action as IV MgSO4 with less side effects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Inhalational magnesium sulfate |
| 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. Receives: Drug: IV Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Airway Pressure (cm H2O)
Measured: from baseline to 12 and 24 hours after administering the study drug
Fraction of Inspired Oxygen (FiO2) (%)
Measured: 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
Measured: 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
Measured: from baseline to 12 and 24 hours after administering the study drug
Secondary outcomes (2)
the Variations in Mean Arterial Blood Pressure (MABP)
Both systolic and diastolic pressure are used to calculate MABP.
Measured: at 0, 12, and 24 hours post administration of the study drug relative to baseline
the Alterations in Serum Magnesium Levels (mmol/L)
Measured: from baseline to 12 hours following the administration of the study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2021
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Magnesium Sulfate - PPHNStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Morsy Saad El Din El Ganady, Benha University
- Investigators
- Osama Z. El Feky, Professor, Study director, Pediatrics Department, Faculty of Medicine, Benha University, Benha, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603766
- Sponsor's protocol ID
- 39-9-204
- Acronym
- PPHN
- Status last verified
- Feb 2025
- First submitted
- 16 Sep 2024
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: demographic data, preliminary clinical data
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Nebuliezed and Intravenous Magnesium Sulfate for Treatment of Persistant Pulmonary Hypertension in Neonates
- ClinicalTrials.gov ID
- NCT06603766
- Acronym / sponsor ID
- PPHN / 39-9-204
- Conditions
- Magnesium Sulfate - PPHN
- Keywords
- PPHN, magnesium sulfate, Neonates
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized magnesium (NebMag) group 1 | Active comparator | Drug: Inhalational magnesium sulfateNebMag 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. |
| Intravenous magnesium (IVMag) group 2 | Active comparator | Drug: IV Magnesium SulfateIVMag 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. |
Who may qualify
- Ages
- 1 hour to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Magnesium SulfateAlso: IV MgSO4MgSO₄'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. | Drug | Intravenous magnesium (IVMag) group 2 |
| Inhalational magnesium sulfateAlso: Inhalational MgSO4It gives us the same mechanism of action as IV MgSO4 with less side effects. | Drug | Nebulized magnesium (NebMag) group 1 |
Primary outcome
Mean Airway Pressure (cm H2O)
Time frame: from baseline to 12 and 24 hours after administering the study drug
Fraction of Inspired Oxygen (FiO2) (%)
Time frame: from baseline to 12 and 24 hours after administering the study drug
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
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
2 secondary outcomes
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
the Alterations in Serum Magnesium Levels (mmol/L)
Time frame: from baseline to 12 hours following the administration of the study drug.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. demographic data, preliminary clinical data
Related trials for Magnesium Sulfate - PPHN
RecruitingPhase 1/2
Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
Persistent Pulmonary Hypertension of Newborn
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Z. El Feky, Professor study director
Pediatrics Department, Faculty of Medicine, Benha University, Benha, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IV Magnesium Sulfate and Inhalational magnesium sulfate in people with Magnesium Sulfate - PPHN, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Airway Pressure (cm H2O) (time frame: from baseline to 12 and 24 hours after administering the study drug). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.