Flash visual evoked potentials in the newborn within first seven days of life.

Establishment of nomograms and reference ranges for flash visual evoked potentials in the newborn and their maturation over the first year of life. - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055285

Enrollment

610

Registered

2023-07-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Visual Evoked Potential: Visual Evoked Potential will be measured for all neonates meeting the inclusion criteria within first seven days of life Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: All neonates delivered at AFMC and Command Hospital (SC), Pune will be included after parental consent.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is to obtain normative data for the latency & amplitude of the major components of Flash- visual evoked potential in newborn at birth. For the same, The mean, standard deviation & 95% CI for the visual latencies (in ms) and amplitudes (in microvolts) will be determined. Graphs plotting the 5th, 50th, and 95th percentile for the various latencies and amplitude of different waveforms of VEP will be generatedTimepoint: At birth(within first 07 days of life)	—

Measure

Time frame

The primary outcome of the study is to obtain normative data for the latency & amplitude of the major components of Flash- visual evoked potential in newborn at birth. For the same, The mean, standard deviation & 95% CI for the visual latencies (in ms) and amplitudes (in microvolts) will be determined. Graphs plotting the 5th, 50th, and 95th percentile for the various latencies and amplitude of different waveforms of VEP will be generatedTimepoint: At birth(within first 07 days of life)

—

Secondary

Measure	Time frame
a) To assess the correlation of gestational age at birth with latency & amplitude of major components of Flash-VEP in newborn b) To assess the correlation of head circumference at birth with latency and amplitude of major components of Flash-VEPTimepoint: At birth	—

Countries

India

Contacts

Public ContactRuchika Jha

Armed Forces Medical College

ruchicls@yahoo.com9556875994

Outcome results