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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium sulphate, neurological outcome | Active Comparator | Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth |
|
| Placebo | Placebo Comparator | Placebo every 24 hours for 3 doses starting from 6 hours after birth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulphate | Drug | 250 mg/kg/dose in 1 ml normal saline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| good short term out come | Death and or abnormal neurological outcome at discharge | at discharge |
| Measure | Description | Time Frame |
|---|---|---|
| abnormal neurological examination and abnormal CT Head | at discharge |
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Inclusion Criteria:
Babies eligible for the study were:
Term or post term
Less than 6 hours of age and had
severe perinatal asphyxia as manifested by any three of the following criteria.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr.Mushtaq A Bhat, M.D. | SKIMS | Principal Investigator |
| Dr.Javeed I Bhat, M.D. | SKIMS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheri-Kashmir Institute of Medical Scienceds | Srinagar | Jammu and Kashmir | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19349375 | Derived | Bhat MA, Charoo BA, Bhat JI, Ahmad SM, Ali SW, Mufti MU. Magnesium sulfate in severe perinatal asphyxia: a randomized, placebo-controlled trial. Pediatrics. 2009 May;123(5):e764-9. doi: 10.1542/peds.2007-3642. Epub 2009 Apr 6. |
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| ID | Term |
|---|---|
| D001237 | Asphyxia |
| ID | Term |
|---|---|
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Normal saline |
| Drug |
1 ml/kg/dose |
|
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |