Magnesium sulfate as an adjunct to cooling of babies who do not cry at birth.

Phase 3

Active, not recruiting

Conditions: Hypoxic ischemic encephalopathy [HIE], Term infants with Hypoxic Ischemic Encephalopathy,

Brief 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 babiesâ€™survival and outcome compared to cooling alone

Recruitment & Eligibility

Inclusion Criteria

Inclusion criteria A plus B and any one of C A.
Inborn babies with Gestational age more than or equal to 37 weeks with Arterial blood gas(Umbilical cord or 1st postnatal hour) pH less than or equal to 7.0 or base deficit more than or equal to 12 meq/L B.
Presence of moderate to severe encephalopathy C.
Any one of the below mentioned criteria: 1.
APGAR less than or equal to 5 at 10 minutes 2.
Evidence of fetal distress 3.
Assisted ventilation for at least 10 minutes after birth 4.
Evidence of any organ dysfunction 5.
History of acute perinatal event.

Exclusion Criteria

Exclusion criteria Infants more than 6 hours of age.

Primary Outcome Measures

Name	Time	Method
Neonatal mortality and/or abnormal neurodevelopmental outcome at 1 year of age	Neonatal mortality at 28 days of life and abnormal neurodevelopmental outcome at 1 year of age

Secondary Outcome Measures

Name	Time	Method
a.Neonatal mortality	b.Major neurodevelopmental disability at 1 year of age

Locations (1): JIPMER, Puducherry
🇮🇳
Pondicherry, PONDICHERRY, India
JIPMER, Puducherry
🇮🇳Pondicherry, PONDICHERRY, India
Dr Chanchal Kumar
Principal investigator
9592244321
drchanchalkumarkem@gmail.com