Magnesium Sulphate in Perinatal Asphyxia - Full Text View

Sponsored by:	Sheri Kashmir Institute of Medical Sciences
Information provided by:	Sheri Kashmir Institute of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00553072

Purpose

magnesium sulphate has been shown to be neuroprotective.We hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve out come in the immediate neonatal period.

Condition	Intervention	Phase
Perinatal Asphyxia	Drug: Magnesium sulphate	Phase III

Drug Information available for: Magnesium Magnesium sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.

Further study details as provided by Sheri Kashmir Institute of Medical Sciences:

Primary Outcome Measures:

good short term out come [ Time Frame: at discharge ]

Secondary Outcome Measures:

abnormal neurological examination and abnormal CT Head [ Time Frame: at discharge ]

Enrollment:	40
Study Start Date:	September 2004
Study Completion Date:	August 2006

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.

Eligibility

Ages Eligible for Study:	up to 12 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Babies eligible for the study were:
1. Term or post term
2. Less than 12 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553072

Locations

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

Sponsors and Collaborators

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

More Information

Study ID Numbers:	SKIMS-001
Study First Received:	November 2, 2007
Last Updated:	November 13, 2007
ClinicalTrials.gov Identifier:	NCT00553072
Health Authority:	India: Institutional Review Board

Keywords provided by Sheri Kashmir Institute of Medical Sciences:

Asphyxia
perinatal
magnesium sulphate

Study placed in the following topic categories:

Calcium, Dietary
Death
Magnesium Sulfate

Wounds and Injuries
Disorders of Environmental Origin
Asphyxia

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Anesthetics
Central Nervous System Depressants
Reproductive Control Agents
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators

Pathologic Processes
Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009