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Magnesium Sulphate in Perinatal Asphyxia (Magsulf)

Primary Purpose

Perinatal Asphyxia , Moderate to Severe HIE

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Magnesium sulphate
Normal saline
Sponsored by
Sheri Kashmir Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perinatal Asphyxia , Moderate to Severe HIE focused on measuring Asphyxia, perinatal, magnesium sulphate

Eligibility Criteria

1 Hour - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheri-Kashmir Institute of Medical Scienceds

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnesium sulphate, neurological outcome

Placebo

Arm Description

Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth

Placebo every 24 hours for 3 doses starting from 6 hours after birth

Outcomes

Primary Outcome Measures

good short term out come
Death and or abnormal neurological outcome at discharge

Secondary Outcome Measures

abnormal neurological examination and abnormal CT Head

Full Information

First Posted
November 2, 2007
Last Updated
October 12, 2016
Sponsor
Sheri Kashmir Institute of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00553072
Brief Title
Magnesium Sulphate in Perinatal Asphyxia
Acronym
Magsulf
Official Title
Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheri Kashmir Institute of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Asphyxia , Moderate to Severe HIE
Keywords
Asphyxia, perinatal, magnesium sulphate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium sulphate, neurological outcome
Arm Type
Active Comparator
Arm Description
Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo every 24 hours for 3 doses starting from 6 hours after birth
Intervention Type
Drug
Intervention Name(s)
Magnesium sulphate
Intervention Description
250 mg/kg/dose in 1 ml normal saline
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
1 ml/kg/dose
Primary Outcome Measure Information:
Title
good short term out come
Description
Death and or abnormal neurological outcome at discharge
Time Frame
at discharge
Secondary Outcome Measure Information:
Title
abnormal neurological examination and abnormal CT Head
Time Frame
at discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Mushtaq A Bhat, M.D.
Organizational Affiliation
SKIMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr.Javeed I Bhat, M.D.
Organizational Affiliation
SKIMS
Official's Role
Study Chair
Facility Information:
Facility Name
Sheri-Kashmir Institute of Medical Scienceds
City
Srinagar
State/Province
Jammu and Kashmir
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
19349375
Citation
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.
Results Reference
derived

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Magnesium Sulphate in Perinatal Asphyxia

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