Magnesium Sulphate in Perinatal Asphyxia (Magsulf)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr.Mushtaq, Sheri Kashmir Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00553072
First received: November 2, 2007
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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 , Moderate to Severe HIE
Drug: Magnesium sulphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Sheri Kashmir Institute of Medical Sciences:

Primary Outcome Measures:
  • good short term out come [ Time Frame: at discharge ] [ Designated as safety issue: Yes ]
    Death and or abnormal neurological outcome at discharge


Secondary Outcome Measures:
  • abnormal neurological examination and abnormal CT Head [ Time Frame: at discharge ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: September 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Magnesium sulphate, neurological outcome
Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth
Drug: Magnesium sulphate
Magnesium sulphate 250mg/kg/dose for 3 doses
Placebo Comparator: Placebo
Placebo every 24 hours for 3 doses starting from 6 hours after birth

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.

  Eligibility

Ages Eligible for Study:   up to 6 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553072

Locations
India
Sheri-Kashmir Institute of Medical Scienceds
Srinagar, Jammu and Kashmir, India
Sponsors and Collaborators
Sheri Kashmir Institute of Medical Sciences
Investigators
Principal Investigator: Dr.Mushtaq A Bhat, M.D. SKIMS
Study Chair: Dr.Javeed I Bhat, M.D. SKIMS
  More Information

No publications provided by Sheri Kashmir Institute of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr.Mushtaq, Professsor, Sheri Kashmir Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00553072     History of Changes
Other Study ID Numbers: SKIMS-001
Study First Received: November 2, 2007
Last Updated: November 29, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Sheri Kashmir Institute of Medical Sciences:
Asphyxia
perinatal
magnesium sulphate

Additional relevant MeSH terms:
Asphyxia
Asphyxia Neonatorum
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 28, 2014