Health Condition 1: null- Babies with perinatal asphyxia (hypoxic ischemic encephalopathy stage 2 and 3)
Conditions
Interventions
Intervention1: Whole body cooling: After obtaining written informed consent from the parents of the babies fulfilling the inclusion criteria, they will be randomized into hypothermia group or control
Sponsors
Department of Biotechnology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gestational age greater than or equal to 37 weeks 2. ABG(umbilical cord or 1st postnatal hour) pH less than or equal to 7 or BE greater than or equal to -12 3. Evidence of encephalopathy (Sarnatâ??s staging 2 or 3) 4. Any two of the following i. APGAR less than or equal to 6 at 5 min ii. Evidence of fetal distress iii. Assisted ventilation for at least 10 min after birth iv. Evidence of any organ dysfunction v. History of acute perinatal event- intrapartum fetal distress, cord prolapse placental abruption, uterine rupture, maternal trauma, cardiac arrest
Exclusion criteria
Exclusion criteria: 1. . Infants more than 6 hours of age at the time of randomization 2. Major congenital abnormalities 3. If the baby does not establish spontaneous respiration by 20 minutes 4. Out born babies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality and developmental delay at 18 months of age in HIE infants of hypothermia and control group using DASII (Developmental Assessment Scale for Indian Infants) and correlating them with the blood levels of neuronal biomarkers.Timepoint: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| difference in the biomarker levels between the two groupsTimepoint: during hospital stay;complications and adverse eventsTimepoint: during hospital stay;cut off values for biomarkers in relation to primary outcomeTimepoint: 18 months;Developmental delayTimepoint: 18 months;MortalityTimepoint: during hospital stay | — |
Countries
India
Contacts
Public ContactDr B Vishnu Bhat
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed