Persistent Fetal CirculationPhase 1/2NebMagNCT04328636
Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn
A Phase 1/2 study testing Nebulized Magnesium Sulfate and Intravenous Magnesium Sulfate in people with Persistent Fetal Circulation and Persistent Pulmonary Hypertension of the Newborn, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this pilot randomized controlled blinded study is to evaluate the feasibility of using nebulized magnesium sulfate in the treatment of PPHN. Read more about this study
- Who is it for?
- Ages 6 to 72 hours
- Conditions the study is for
- Persistent Fetal Circulation, Persistent Pulmonary Hypertension of the Newborn, PPHN
- What is being tested?
- Nebulized Magnesium Sulfate and Intravenous Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 1 Aug 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 6 to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with PPHN fulfilling the following:
- born at ≥ 37 weeks gestational age.
- birth weight between 2.5 and 4 kg.
- post-natal age between 6 and 72 hours.
- connected to mechanical ventilation with an oxygenation index (OI) > 30 on two occasions at least 15 minutes apart.
- documented PPHN confirmed by echocardiography.
Who cannot join
- failure to obtain informed consent.
- infants of mothers who received magnesium sulfate within 48 hours before labor.
- congenital heart diseases (other than 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 inotrpic support.
- impaired kidney function.
- prior administration of pulmonary vasodilators.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Unit, Sohag University Hospital
Sohag, 82524
About this study
Official title: Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of The Newborn
The aim of this pilot randomized controlled blinded study is to evaluate the feasibility of using nebulized magnesium sulfate in the treatment of PPHN.
Read the detailed description
The effectiveness and safety of nebulized magnesium sulfate (using isotonic solution in a dose of 1024 mg/hour) is compared with intravenous magnesium sulfate (200 mg/kg over 30 minutes, followed by 50 mg/kg/hour) in treating mechanically ventilated neonates with severe persistent pulmonary hypertension of the newborn.
- Being tested
- Nebulized Magnesium Sulfate, Intravenous Magnesium Sulfate
- Keywords
- neonate, persistent fetal circulation, persistent pulmonary hypertension of the newborn, PPHN, Magnesium Sulfate, Nebulizer, hypoxia
- Medical subject headings
- Persistent Fetal Circulation Syndrome, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized Magnesium SulfateDrug
Nebulized magnesium sulfate (isotonic solution) 256 mg every 15 minutes
Intravenous Magnesium SulfateDrug
Intravenous magnesium sulfate 200 mg/kg over 30 minutes, followed by a continuous infusion at a rate of 50 mg/kg/hour
| Study group | Role | What they receive |
|---|---|---|
| NebMag | Experimental | Neonates with PPHN receiving nebulized magnesium sulfate and intravenous placebo Receives: Drug: Nebulized Magnesium Sulfate |
| IVMag | Active comparator | Neonates with PPHN receiving intravenous magnesium sulfate and nebulized placebo Receives: Drug: Intravenous Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index (OI)
Change in oxygenation index (OI) calculated by the classic formula:
OI = [(FiO2 * MAP) / PaO2]
FiO2 expressed in %; MAP in cmH2O/mmHg; and PaO2 in mmHg
Measured: At baseline to 2, 6, 12, and 24 hours following study drug administration.
Secondary outcomes (3)
Mean arterial blood pressure (MABP)
Changes in mean arterial blood pressure
Measured: At baseline to 2, 6, 12, and 24 hours following study drug administration.
Serum magnesium level
Changes in serum magnesium level
Measured: At baseline to 12 hours after study drug adminstration
Vasoactive Inotropic Score (VIS)
Changes in VIS calculated by the classic 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)
Measured: At baseline to 2, 6, 12, and 24 hours following study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Nov 2017
- Primary completion1 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Fetal CirculationStudies of the same condition, open and under way.
- More trials run by Sohag 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of neonates with PPHN 1. NebMag group: receive nebulized magnesium sulfate and intravenous placebo. 2. IVMag group: receive intravenous magnesium sulfate and nebulized placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Abdelkreem, Sohag University
- Investigators
- Elsayed Abdelkreem, MD, PhD, Principal investigator, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328636
- Sponsor's protocol ID
- NebMag-PPHN Study
- Acronym
- NebMag
- Status last verified
- Aug 2020
- First submitted
- 29 Mar 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelkreem E, Mahmoud SM, Aboelez MO, Abd El Aal M. Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of Newborn: A Pilot Randomized Controlled Trial. Indian J Pediatr. 2021 Aug;88(8):771-777. doi: 10.1007/s12098-020-03643-y. Epub 2021 Jan 8.
PubMed 33415555
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of The Newborn
- ClinicalTrials.gov ID
- NCT04328636
- Acronym / sponsor ID
- NebMag / NebMag-PPHN Study
- Keywords
- neonate, persistent fetal circulation, persistent pulmonary hypertension of the newborn, PPHN, Magnesium Sulfate, Nebulizer, hypoxia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this pilot randomized controlled blinded study is to evaluate the feasibility of using nebulized magnesium sulfate in the treatment of PPHN.
Detailed description
The effectiveness and safety of nebulized magnesium sulfate (using isotonic solution in a dose of 1024 mg/hour) is compared with intravenous magnesium sulfate (200 mg/kg over 30 minutes, followed by 50 mg/kg/hour) in treating mechanically ventilated neonates with severe persistent pulmonary hypertension of the newborn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups of neonates with PPHN 1. NebMag group: receive nebulized magnesium sulfate and intravenous placebo. 2. IVMag group: receive intravenous magnesium sulfate and nebulized placebo.
| Arm | Type | Receives |
|---|---|---|
| NebMag | Experimental | Drug: Nebulized Magnesium SulfateNeonates with PPHN receiving nebulized magnesium sulfate and intravenous placebo |
| IVMag | Active comparator | Drug: Intravenous Magnesium SulfateNeonates with PPHN receiving intravenous magnesium sulfate and nebulized placebo |
Who may qualify
- Ages
- 6 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- born at ≥ 37 weeks gestational age.
- birth weight between 2.5 and 4 kg.
- post-natal age between 6 and 72 hours.
- connected to mechanical ventilation with an oxygenation index (OI) > 30 on two occasions at least 15 minutes apart.
- documented PPHN confirmed by echocardiography.
Key exclusion criteria (8 listed)
- failure to obtain informed consent.
- infants of mothers who received magnesium sulfate within 48 hours before labor.
- congenital heart diseases (other than 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 |
|---|---|---|
| Nebulized Magnesium SulfateNebulized magnesium sulfate (isotonic solution) 256 mg every 15 minutes | Drug | NebMag |
| Intravenous Magnesium SulfateIntravenous magnesium sulfate 200 mg/kg over 30 minutes, followed by a continuous infusion at a rate of 50 mg/kg/hour | Drug | IVMag |
Primary outcome
Oxygenation index (OI)
Time frame: At baseline to 2, 6, 12, and 24 hours following study drug administration.
Change in oxygenation index (OI) calculated by the classic formula: OI = [(FiO2 * MAP) / PaO2] FiO2 expressed in %; MAP in cmH2O/mmHg; and PaO2 in mmHg
3 secondary outcomes
Mean arterial blood pressure (MABP)
Time frame: At baseline to 2, 6, 12, and 24 hours following study drug administration.
Serum magnesium level
Time frame: At baseline to 12 hours after study drug adminstration
Vasoactive Inotropic Score (VIS)
Time frame: At baseline to 2, 6, 12, and 24 hours following study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Derived from this study: PubMed 33415555Abdelkreem E, Mahmoud SM, Aboelez MO, Abd El Aal M. Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of Newborn: A Pilot Randomized Controlled Trial. Indian J Pediatr. 2021 Aug;88(8):771-777. doi: 10.1007/s12098-020-03643-y. Epub 2021 Jan 8.
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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.
Elsayed Abdelkreem, MD, PhD principal investigator
Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nebulized Magnesium Sulfate and Intravenous Magnesium Sulfate in people with Persistent Fetal Circulation and Persistent Pulmonary Hypertension of the Newborn, run by Sohag 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 6 inclusion and 8 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 18 Aug 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oxygenation index (OI) (time frame: At baseline to 2, 6, 12, and 24 hours following study drug administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04328636, which also lists 1 linked publication.
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 18 Aug 2020.