Whole body cooling for neonates with delayed cry at birth
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Term neonates with perinatal asphyxia
- Registration Number
- CTRI/2011/06/001780
- Lead Sponsor
- Dr Vishnu Bhat B
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of mortality between the hypothermia group and the control group <br/ ><br> -Morbidity between the hypothermia and control group upto 6 months of age <br/ ><br>Timepoint: Rate of mortality between the hypothermia group and the control group at discharge and at 6 months <br/ ><br> -Morbidity between the hypothermia and control group upto 6 months of age <br/ ><br>
- Secondary Outcome Measures
Name Time Method Intracranial hemorrhage,pulmonary hemorrhage,pulmonary hypertension,culture proven sepsis,NEC(necrotising enterocolitis),renal failure,duration of hospitalization,pneumonia,frequency of convulsionsTimepoint: during hospital stay