NCT00553072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
Last Updated

October 14, 2016

Status Verified

November 1, 2013

Enrollment Period

1.9 years

First QC Date

November 2, 2007

Last Update Submit

October 12, 2016

Conditions

Perinatal Asphyxia , Moderate to Severe HIE

Keywords

Asphyxiaperinatalmagnesium sulphate

Outcome Measures

Primary Outcomes (1)

  • good short term out come

    Death and or abnormal neurological outcome at discharge

    at discharge

Secondary Outcomes (1)

  • abnormal neurological examination and abnormal CT Head

    at discharge

Study Arms (2)

Magnesium sulphate, neurological outcome

ACTIVE COMPARATOR

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

Drug: Magnesium sulphate

Placebo

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Magnesium sulphateDRUG

250 mg/kg/dose in 1 ml normal saline

Magnesium sulphate, neurological outcome
Normal salineDRUG

1 ml/kg/dose

Placebo

Eligibility Criteria

Age1 Hour - 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheri-Kashmir Institute of Medical Scienceds

Srinagar, Jammu and Kashmir, India

Location

Related Publications (1)

  • 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.

    PMID: 19349375DERIVED

MeSH Terms

Conditions

Asphyxia

Interventions

Magnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Dr.Mushtaq A Bhat, M.D.

    SKIMS

    PRINCIPAL INVESTIGATOR

  • Dr.Javeed I Bhat, M.D.

    SKIMS

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professsor

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 5, 2007

Study Start

September 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

October 14, 2016

Record last verified: 2013-11

Locations

IN(1)