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Magnesium Sulphate in Perinatal Asphyxia (Magsulf)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00553072
Recruitment Status : Completed
First Posted : November 4, 2007
Last Update Posted : October 14, 2016
Information provided by (Responsible Party):
Dr.Mushtaq, Sheri Kashmir Institute of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Perinatal Asphyxia , Moderate to Severe HIE Drug: Magnesium sulphate Drug: Normal saline Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.
Study Start Date : September 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Magnesium sulphate, neurological outcome
Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth
Drug: Magnesium sulphate
250 mg/kg/dose in 1 ml normal saline

Placebo Comparator: Placebo
Placebo every 24 hours for 3 doses starting from 6 hours after birth
Drug: Normal saline
1 ml/kg/dose

Primary Outcome Measures :
  1. good short term out come [ Time Frame: at discharge ]
    Death and or abnormal neurological outcome at discharge

Secondary Outcome Measures :
  1. abnormal neurological examination and abnormal CT Head [ Time Frame: at discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Babies eligible for the study were:

    1. Term or post term
    2. Less than 6 hours of age and had
    3. severe perinatal asphyxia as manifested by any three of the following criteria.

      • History of fetal distress (late deceleration, Loss of beat to beat variability, fetal bradycardia, meconium stained amniotic fluid)
      • Need for immediate neonatal ventilation with bag and mask or through endotracheal intubation for 2 minutes or more after delivery
      • A 5-minute Apgar score of < 6
      • Base deficit 15 mEq/L in cord blood or admission arterial or cord blood pH 4.Moderate to severe encephalopathy

Exclusion Criteria:

  • Patients with severe IUGR
  • Any condition unrelated to asphyxia
  • Maternal prenatal magnesium administration
  • Metabolic disorder
  • Chromosomal anomalies; and
  • Congenital malformations were excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00553072

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Sheri-Kashmir Institute of Medical Scienceds
Srinagar, Jammu and Kashmir, India
Sponsors and Collaborators
Sheri Kashmir Institute of Medical Sciences
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Principal Investigator: Dr.Mushtaq A Bhat, M.D. SKIMS
Study Chair: Dr.Javeed I Bhat, M.D. SKIMS
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr.Mushtaq, Professsor, Sheri Kashmir Institute of Medical Sciences Identifier: NCT00553072    
Other Study ID Numbers: SKIMS-001
First Posted: November 4, 2007    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: November 2013
Keywords provided by Dr.Mushtaq, Sheri Kashmir Institute of Medical Sciences:
magnesium sulphate
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents