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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049314
Enrollment
3050
Registered
2023-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

None listed

Interventions

Intervention1: VEP will be performed at birth and at 3, 6, 9, and 12 months of chronological age.: VEP will be performed at birth and at 3, 6, 9, and 12 months of chronological age. Control Interventi

Sponsors

Office of DGAFMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates delivered at AFMC and Command Hospital (SC), Pune and all infants presenting at 3, 6, 9, and 12 months of age 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

MeasureTime frame
The primary outcome of the study is to obtain normative data for the latency and amplitude of the major components of Flash- visual evoked potential in newborn and at 3, 6, 9 and 12 months of life. For the same, The mean, standard deviation and 95% CI for the visual latencies (in ms) and amplitudes (in microvolts) will be determined at all age groups. Graphs plotting the 5th, 50th, and 95th percentile for the various latencies and amplitude of different waveforms of VEP will be generatedTimepoint: The primary outcome of the study is to obtain normative data for the latency and amplitude of the major components of Flash- visual evoked potential in newborn and at 3, 6, 9 and 12 months of life. For the same, The mean, standard deviation and 95% CI for the visual latencies (in ms) and amplitudes (in microvolts) will be determined at all age groups. Graphs plotting the 5th, 50th, and 95th percentile for the various latencies and amplitude of different waveforms of VEP will be generated

Secondary

MeasureTime frame
a) To assess the correlation of gestational age at birth with latency and amplitude of major components of Flash-VEP in newborn b) To assess the correlation of head circumference at birth, 3, 6, 9 and 12 months of life with latency and amplitude of major components of Flash-VEP Timepoint: Flash-VEP in newborns and at 3, 6, 9 and 12 months of life.

Countries

India

Contacts

Public ContactRuchika Jha

Armed Forces Medical College

ruchicls@yahoo.com9556875994

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026