Flash visual evoked potentials in the newborn within first seven days of life.
Phase 1
- Registration Number
- CTRI/2023/07/055285
- Lead Sponsor
- Office of Director General Armed Forces Medical Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All neonates delivered at AFMC and Command
Hospital (SC), Pune will be included
after parental consent.
Exclusion Criteria
a) Neonates with perinatal insults including perinatal asphyxia,
hypoxia, shock, sepsis, needing respiratory support or any systemic
dysfunction
b) Neonates/ children with known genetic or chromosomal disorder
c) Neonates/ children with clearly identified familial or non-familial
syndromes
d) Neonates/ infants diagnosed with progressive or
neurodegenerative disorders
e) Neonates/ infants diagnosed with visual impairment will be
excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of the study is to obtain <br/ ><br>normative data for the latency & amplitude of <br/ ><br>the major components of Flash- visual evoked <br/ ><br>potential in newborn at birth. For the same, The mean, <br/ ><br>standard deviation & 95% CI for the visual <br/ ><br>latencies (in ms) and amplitudes (in microvolts) <br/ ><br>will be determined. Graphs <br/ ><br>plotting the 5th, 50th, and 95th percentile for the <br/ ><br>various latencies and amplitude of different <br/ ><br>waveforms of VEP will be generatedTimepoint: At birth(within first 07 days of life)
- Secondary Outcome Measures
Name Time Method a) To assess the correlation of gestational age at <br/ ><br>birth with latency & amplitude of major <br/ ><br>components of Flash-VEP in newborn <br/ ><br>b) To assess the correlation of head <br/ ><br>circumference at birth with latency and amplitude of major <br/ ><br>components of Flash-VEPTimepoint: At birth