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Completed

NCT Number: NCT00553072

Magnesium Sulphate in Perinatal Asphyxia

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.

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Key information

Age range

1 hour–6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sheri-Kashmir Institute of Medical Scienceds

Srinagar, Jammu and Kashmir, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulphate

Drug

250 mg/kg/dose in 1 ml normal saline

normal saline

Drug

1 ml/kg/dose

Primary outcomes

  1. good short term out come

    Time frame: at discharge

    Death and or abnormal neurological outcome at discharge

Secondary outcomes

  1. abnormal neurological examination and abnormal CT Head

    Time frame: at discharge

Sponsors and collaborators

Lead sponsor

Sheri Kashmir Institute of Medical Sciences

Other

Registry information

Official study title

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

Acronym: Magsulf

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Nov 5, 2007
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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