A study to determine the efficacy of restricted fluid administration in improving health of babies who have brain injury due to less oxygen during birth.
Phase 3
Completed
- Conditions
- Health Condition 1: 3- AdministrationHealth Condition 2: null- Neonates with perinatal asphyxiaHealth Condition 3: P039- Newborn affected by complication of labor and delivery, unspecified
- Registration Number
- CTRI/2017/03/008156
- Lead Sponsor
- Diamond Jubilee Society Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
Inclusion Criteria
neonate with perinatal asphyxia
Exclusion Criteria
neonate with congenital malformation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PRIMARY OUTCOME: Neonatal mortality or severe neurodevelopmental disability at discharge. <br/ ><br>Timepoint: at discharge. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1)electrolyte disturbances <br/ ><br> <br/ ><br>2)Urine output1ml/kg/h during the first three days of life. <br/ ><br>3)Abnormal renal function after the first 24 hours of life as a reflection of the asphyxia insult . <br/ ><br>4)Seizures requiring anticonvulsants: detection of seizures based on either clinical grounds,detection by electroencephalogram, or by treatment of seizures with antiepilectic treatment. <br/ ><br>5) CT or MRI changes consistent with asphyxia <br/ ><br>Timepoint: electrolytes on day 1 and day 2 <br/ ><br>urine output on day 1,2 and 3 <br/ ><br>Renal function on day 2 <br/ ><br>seizures during admission(day 1-7) <br/ ><br>MRI at discharge <br/ ><br> <br/ ><br>