Health Condition 1: P039- Newborn affected by complication of labor and delivery, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria includes 1. patients with history and documentation of perinatal asphyxia, periventricular leukomalacia, hypoglycemia, perinatal infections, genetic, metabolic, hydrocephalus, or structural causes or 2. documented perinatal brain damage confirmed by a pediatric neurologist along with 3. MRI evidence of brain injury in a pattern typical of hypoxic-ischemic encephalopathy (HIE) including peri-ventricular leukomalacia (PVL) 4. problems in visual functioning (corroborated by results of functional vision assessment) or atypical neuro-visuo-behavior or visual perceptual or cognitive dysfunction on CVI inventory questionnaire and 5. confirmed on examination with at least 2 or more of the following: a) Deficit or impaired visual inattention, fixation, or inability to follow objects; b)Deficit visual guided reach or visual guidance of upper limbs (inability to reach out or hold a toy or difficulty in picking up a toy); c) Deficit visual communication/search/curiosity/ spatial orientation; d)Deficit visual processing like recognition of face/objects/facial expression or Difficulty with clutter
Exclusion criteria
Exclusion criteria: • Children with pediatric cataracts, corneal pathologies, retinal pathologies, or dense amblyopia responsible for low vision • Retinopathy of prematurity of grade 4 or 5, and major ROP sequelae like falciform fold involving disc or macula nonresolving macular bleed, vitreous hemorrhage assessed by a paediatric ophthalmologist • Children with epileptic spasms, electroclinical epileptic encephalopathy, seizure frequency of more than one/month in the past 3 months or patients using anti-epileptic vigabatrin • Children with debilitating illnesses requiring immediate attention • Children whose caregivers refuse to participate in the study • Autistic children
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is improvement in FUNCTIONAL VISION in terms of 1. improvement in visual acuity, 2. visual attention (attention span, reaction time and number of orienting responses), 3. achieving steadiness of visual fixation, 4. improvement in visual communication, 5. improvement in visual guidance of limbs or visuomotor tasks 6. improvement in visual perception including cognition, recognition Timepoint: outcome will be assessed at the end of 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Imaging findings and correlation of imaging findings with clinical findings â?¢ pre and post electrophysiologic findings (Improvement in P100 latency) findings and correlation of imaging findings with clinical findingsTimepoint: at end of 1 year | — |
Countries
India
Contacts
Post Graduate Institute of Medical Education and Research