Effect of temperature on oxidative stress on birth asphyxia in term babies
Phase 4
Completed
- Conditions
- Health Condition 1: null- term neonates with perinatal asphyxia
- Registration Number
- CTRI/2011/12/002196
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
Inclusion Criteria
Inborn babies with : 1+2+3 + any one of 4
1.Gestational, age >= 37 weeks
2.ABG(umbilical cord or 1st postnatal hour
pH <=7 or Base deficit >= 12meq
3.Evidence of encephalopathy
(THOMPSON SCORE >5)
4.Any one of the following
i.APGAR <=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
i.Infants >6 hours of age at the time of randomisation
ii.Major congenital abnormalities
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 evel of Total antioxidant status(TAS), Malondialdehyde (MDA)in both the groups.Timepoint: At birth and at 72 hours of age in both groups
- Secondary Outcome Measures
Name Time Method Death, neurological disability at discharge in both the groups <br/ ><br> <br/ ><br>Timepoint: followed up till discharge from hospital