Health Condition 1: null- Term neonates with perinatal asphyxia
Conditions
Interventions
Intervention1: cooling gel packs: whole body cooling initiated using the cooling gel packs used in vaccine vial carriers within 6 hrs of birth and continued upto 72 hours of life with skin and rectal
Sponsors
Dr Vishnu Bhat B
Eligibility
Inclusion criteria
Inclusion criteria: Inborn babies - 1.Gestational age ≥ 37 weeks 2.ABG(umbilical cord or 1st postnatal hour) pH ≤7 or BE ≥ -12 3.Evidence of encephalopathy 4.Any two of the following i. APGAR ≤6 at 5 min ii. Evidence of fetal distress iii. Assisted ventilation for atleast 10 min after birth iv. Evidence of any organ dysfunction v. History of acute perinatal event- intrpartum fetal distress,cord prolapse placental abruption ,uterine rupture, maternal trauma,cardiac arrest
Exclusion criteria
Exclusion criteria: i. Infants 6 hours of age at the time of randomization. ii.Major congenital abnormalies iii. If the baby does not establish spontaneous respiration by 20 minutes iv. outborn babies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of mortality between the hypothermia group and the control group -Morbidity between the hypothermia and control group upto 6 months of age Timepoint: Rate of mortality between the hypothermia group and the control group at discharge and at 6 months -Morbidity between the hypothermia and control group upto 6 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial hemorrhage,pulmonary hemorrhage,pulmonary hypertension,culture proven sepsis,NEC(necrotising enterocolitis),renal failure,duration of hospitalization,pneumonia,frequency of convulsionsTimepoint: during hospital stay | — |
Countries
India
Contacts
Public ContactShruthi K Bharadwaj
Outcome results
None listed