Magnesium Sulphate in Perinatal Asphyxia

Perinatal Asphyxia , Moderate to Severe HIE Clinical Trial

— Magsulf  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553072
• Other study ID #: SKIMS-001
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2007
• Last updated: October 12, 2016
• Start date: September 2004
• Est. completion date: August 2006

Study information

• Verified date: November 2013
• Source: Sheri Kashmir Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Hours

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Perinatal Asphyxia , Moderate to Severe HIE

Intervention

Drug:
• Magnesium sulphate
250 mg/kg/dose in 1 ml normal saline
• Normal saline
1 ml/kg/dose

Locations

Country	Name	City	State
India	Sheri-Kashmir Institute of Medical Scienceds	Srinagar	Jammu and Kashmir

Sponsors (1)

Lead Sponsor	Collaborator
Sheri Kashmir Institute of Medical Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	good short term out come	Death and or abnormal neurological outcome at discharge	at discharge	Yes
Secondary	abnormal neurological examination and abnormal CT Head		at discharge	Yes