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NCT06342362

Magnesium Sulfate in Neonatal HIE"

Status unknown Phase 4 Last updated 2 April 2024
What this trial tests

Phase 4 trial testing Magnesium sulfate in Neonates With HIE in 102 participants. Status unknown.

Timeline
2 April 2024
Primary endpoint
2 October 2024
2 December 2024

Quick facts

Lead sponsorSindh Institute of Child Health and Neonatology
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment102
Start date2 April 2024
Primary completion2 October 2024
Estimated completion2 December 2024
Sites1 location across Pakistan

Drugs / interventions tested

Conditions studied

Sponsor

Sindh Institute of Child Health and Neonatology

Who can join

Adults 1 Day to 30 Days, any sex, with Neonates With HIE. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital. Using a randomized clinical trial design, the study targets term and near-term newborns with moderate to severe HIE. Data collection involves obtaining informed consent, preparing and administering magnesium sulfate, and assessing outcomes including mortality and morbidity. The study aims to provide insights into improving patient outcomes and clinical practice for neonatal HIE management.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pharmacological Therapies for Consequences of Perinatal Hypoxic-Ischemic Brain Injury: Where Are We Now?
    Gebala P, Janowska J, Sypecka J. · · 2025 · PMID 41155490 · DOI 10.3390/ijms262010200
  2. Antioxidant Therapy in Neonatal Hypoxic Ischemic Encephalopathy: Adjuvant or Future Alternative to Therapeutic Hypothermia?
    Notarbartolo V, Badiane BA, Angileri VM, Piro E, et al · · 2024 · PMID 39590867 · DOI 10.3390/metabo14110630

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