A clinical trial to study hemodynamics in cooled and non cooled neonates with Birth asphyxia
Not Applicable
- Conditions
- Health Condition 1: null- NEONATES WITH HYPOXIC ISCHEMIC ENCEPHALOPATHYHealth Condition 2: I998- Other disorder of circulatory systemHealth Condition 3: I998- Other disorder of circulatory system
- Registration Number
- CTRI/2017/01/007735
- Lead Sponsor
- Department of Neonatology Institute of child health and hospital for children
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
1.Age < 6 hours, Birth-weight >1.8kg, Gestation >36 weeks based on available
information regarding last menstrual period or ultrasound) AND
2.Need for continued resuscitation at 5 minutes of age and/or 5 minute Apgar
score <6 (for babies born at hospital) or lack of cry by 5 minutes of age
(for babies born at home) AND
3. Evidence of moderate or severe encephalopathy at < 6 hours of age on a
structured clinical examination
Exclusion Criteria
1.Congenital heart disease (VSD/ASD/PDA)
2.SEVERE PPHN on Admission
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Trend of Fractional Shortening among cooled and non-cooled neonates with moderate to severe hypoxic ischemic encephalopathy upto 96 hrs from the time of admission in NICUTimepoint: At 1 hour after admission in NICU, and then every 8 ± 2 hours till 96hrs of age
- Secondary Outcome Measures
Name Time Method 1.Trend of Ejection fraction <br/ ><br>2.Trend of Mean velocity of circumferential fiber shortening <br/ ><br>3.Trend of Cardiac output <br/ ><br>4.Trend of SVC flow <br/ ><br>5.Trend of IVC collapsibility index <br/ ><br>6.Correlation of Heart rate with Fractional shortening <br/ ><br>7.Correlation of Mean blood Pressure with Fractional shortening <br/ ><br>8.Correlation of LACTATE levels with Fractional shortening <br/ ><br>9.Correlation of Cardio-Troponin I levels with Fractional shortening <br/ ><br>10.Incidence of hypotension (MBP40mmhg) <br/ ><br>Timepoint: At 1 hour after admission in NICU, and then every 8 ± 2 hours till 96hrs of age