Health Condition 1: null- Hypoxic Ischemic Encephalopathy
Conditions
Interventions
Intervention1: Term newborns with birth asphyxia meeting inclusion criterias.: They will receive therapeutic hypothermia same as the comparator group plus three intra-venous doses of magnesium sulphat
Sponsors
Pt B D sharma health university
Eligibility
Inclusion criteria
Inclusion criteria: A) Essential criterias : ( all three criterias should be met ) 1. Infants of more than 36 weeks of gestational period. 2. Admitted to NICU within 6 hrs of birth. 3. Birth weight more than 2000gm. B) Evidence of birth asphyxia ( any one of the following should be met ) 1. Apgar score less than 5 at 5 minutes after birth due to birth asphyxia/perinatal depression. 2. Continued need for resuscitation, including endotracheal or mask ventilation at 5 minutes after birth. 3. Acidosis within 60 minutes of birth defined as any occurrence of umbilical cord/arterial capillary pH less than 7.00 4. Base deficit more than 16 mmol/l in umbilical cord or any blood sample taken within 60 minutes of birth C) Evidence of encephalopathy ( any one of the following should be met ) 1. Clinical seizures 2. Evidence of moderate to severe encephalopathy, consisting of altered state of consciousness including lethargy, stupor or coma and at least one of the following; a. Hypotonia b. Abnormal reflexes including occulomotor or pupillary reflexes c. Absent or weak suck
Exclusion criteria
Exclusion criteria: 1. Babies with gross congenital malformation. 2. Treatment of mother with magnesium sulphate for pregnancy induced hypertension. 3. Babies with little chance to survive.( Apgar score less than 1 at 10 minutes ) 4. Infants received after 6 hrs of birth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined outcome of mortality or abnormal neurological examination at time of dischargeTimepoint: Discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Abnormal MRI findingTimepoint: one month;abnormal neurological examinationTimepoint: one month | — |
Countries
India
Contacts
Public ContactDr Geeta Gathwala
Pt B D Sharma PGIMS Rohtak
Outcome results
None listed