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Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy

NCT01646619 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-04-04

No results posted yet for this study

Summary

The purpose of this study is to assess whether the addition of a drug such as Magnesium sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated at birth provides additional benefit to the babies' survival and outcome compared to cooling alone.

Conditions

  • Severe Hypoxic Ischemic Encephalopathy
  • Moderate Hypoxic Ischemic Encephalopathy

Interventions

DRUG

Magnesium Sulphate

10% MgSo4 (100mg/ml) given in a dose of 250mg/kg IV q 24 hrly for 3 doses(2.5ml/kg). Diluent: Dextrose 5%.

DRUG

Placebo

Normal Saline 0.9% Sodium Chloride is diluted in 5% Dextrose to be given as 2.5ml/kg IV q24 hrly for 3 doses.

Sponsors & Collaborators

  • Sajjad Rahman

    lead INDUSTRY

Principal Investigators

  • Sajjad Ur Rahman, MBBS.DCH.MCPS.FCPS.FRCPCH.FNP · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-12-31
Completion
2014-06-30

Countries

  • Egypt
  • Malaysia
  • Qatar
  • Saudi Arabia
  • Turkey (Türkiye)
  • United Arab Emirates

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01646619 on ClinicalTrials.gov