Magnesium Sulphate in Perinatal Asphyxia (Magsulf)

October 12, 2016 updated by: Dr.Mushtaq, Sheri Kashmir Institute of Medical Sciences

Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Jammu and Kashmir
      • Srinagar, Jammu and Kashmir, India
        • Sheri-Kashmir Institute of Medical Scienceds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 6 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
good short term out come
Time Frame: at discharge
Death and or abnormal neurological outcome at discharge
at discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
abnormal neurological examination and abnormal CT Head
Time Frame: at discharge
at discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 4, 2007

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKIMS-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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