A scientific study to compare the role of reduced intravenous fluid administration versus normal intravenous fluid administration on the death and developmental outcome among newborns with perinatal asphyxia treated with therapeutic hypothermia.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Term newborns with birth asphyxia
- Registration Number
- CTRI/2016/11/007431
- Lead Sponsor
- JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Gestational, age >= 36 weeks
ABG(umbilical cord or 1st postnatal hour
pH <=7 or Base deficit >= 12 meq
OR
i.APGAR <=5 at 10 min
ii.Assisted ventilation for at least 10 min after birth
iii.History of acute perinatal event- intrapartum fetal distress, cord prolapse placental abruption .
Above criteria in presence of moderate or severe encephalopathy by clinical examination.
Exclusion Criteria
i.Infants >6 hours of age at the time of randomization.
ii.Major congenital abnormalities.
iii.Maternal renal failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare the composite outcome of death or major neurodevelopmental disability at 6 months of age between fluid restricted and non fluid restricted groups. <br/ ><br>Timepoint: Six months of life.
- Secondary Outcome Measures
Name Time Method 1.To study the changes in serum electrolytes, serum osmolarity, renal and neurological clinical parameters between term asphyxiated newborns treated with fluid restriction and without fluid restriction. <br/ ><br> <br/ ><br>. <br/ ><br>2.To correlate the parameters like change in serum sodium, change in serum osmolarity, incidence of hypoglycemia, incidence of acute kidney injury, incidence of shock and neonatal seizures to outcome. <br/ ><br>Timepoint: At six months of life.