Using magnesium sulfate to protect the brain in preterm births
The Neuroprotective Impact of Magnesium Sulphate Therapy for Preterm Deliveries. Loading Dose Alone Strategy Versus Loading Plus Maintenance Dose Strategy.
This study is testing if giving magnesium sulfate in a simpler way can help protect the brains of babies born early from serious problems like cerebral palsy and death.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 24 Weeks to 34 Weeks |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Sharkia) |
| Trial ID | NCT05674565 on ClinicalTrials.gov |
What this trial studies
This study investigates the neuroprotective effects of magnesium sulfate in women at risk of preterm birth, specifically focusing on those between 24 and 34 weeks of gestation. It compares the outcomes of a loading dose followed by maintenance therapy against a loading dose only, addressing the gap in knowledge regarding the effectiveness of shorter treatment regimens. The goal is to determine if a simplified approach can still provide adequate neuroprotection for infants at risk of conditions like cerebral palsy and neonatal death. The study aims to improve treatment protocols and reduce healthcare costs associated with prolonged therapies.
Who should consider this trial
Good fit: Ideal candidates are women between 24+0 and 33+6 weeks of gestation who are at risk of imminent preterm birth.
Not a fit: Patients who have known hypersensitivity to magnesium or are expected to deliver after 34 weeks will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of cerebral palsy and neonatal death in preterm infants.
How similar studies have performed: Previous studies have indicated the neuroprotective role of magnesium sulfate, but this specific approach of comparing loading doses has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women at risk of preterm birth who are between 24+0 and 33+6 weeks of gestation. 2. When early preterm birth is planned or expected within 24 h, regardless of: * Plurality or parity * Reason for the risks of preterm birth * Anticipated mode of birth * Whether antenatal corticosteroids have been given or not Exclusion Criteria: * Women with known Hypersensitivity to magnesium * Caution regarding dosage for patients with renal impairment * Preterm delivery after 34 weeks
Where this trial is running
Zagazig, Sharkia
- Faculty of medicine, Zagazig University — Zagazig, Sharkia, Egypt (Recruiting)
Study contacts
- Principal investigator: Amro Alnemr, M.D. — Zagazig University
- Study coordinator: Hytham Atia, M.D
- Email: hythamatia@gmail.com
- Phone: +9660538308500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.