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Sponsored by: |
Sheri Kashmir Institute of Medical Sciences |
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Information provided by: | Sheri Kashmir Institute of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00553072 |
Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in the immediate neonatal period.
Condition | Intervention | Phase |
---|---|---|
Perinatal Asphyxia |
Drug: Magnesium sulphate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial. |
Enrollment: | 40 |
Study Start Date: | September 2004 |
Study Completion Date: | August 2006 |
Magnesium sulphate has a neuroprotective potential as has been shown by many studied in pregnant ladies with eclampsia where it helped neonates also and in mothers with preterm labour where the incidence of cerebral palsy was less. We designed a randomised controlled trial on 40 neonates with severe perinatal asphyxia to see whether it helps in the short term outcome of these neonates.
Ages Eligible for Study: | up to 6 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Babies eligible for the study were:
severe perinatal asphyxia as manifested by any three of the following criteria.
Exclusion Criteria:
India, Jammu and Kashmir | |
Sheri-Kashmir Institute of Medical Scienceds | |
Srinagar, Jammu and Kashmir, India |
Principal Investigator: | Dr.Mushtaq A Bhat, M.D. | SKIMS |
Study Chair: | Dr.Javeed I Bhat, M.D. | SKIMS |
Study ID Numbers: | SKIMS-001 |
Study First Received: | November 2, 2007 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00553072 |
Health Authority: | India: Institutional Review Board |
Asphyxia perinatal magnesium sulphate |
Calcium, Dietary Death Magnesium Sulfate |
Wounds and Injuries Disorders of Environmental Origin Asphyxia |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Blockers Anesthetics Central Nervous System Depressants Reproductive Control Agents Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators |
Pathologic Processes Tocolytic Agents Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Central Nervous System Agents Anticonvulsants |