Neonatal convulsions
Conditions
Interventions
Sponsors
Máxima MC
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: Newborns treated for neonatal convulsions in the NICU of Radboud UMC between 01-01-2010 and 31-12-2022.Newborns had refractory neonatal convulsions with treatment of at least two antiepileptic drugs.A pyridoxine trial was conducted in which the newborn received at least 100 mg of pyridoxine.
Exclusion criteria
Exclusion criteria: Exclusion criterion: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure of the study is the evaluation of neurodevelopmental impairment (NDI) and is defined as a composite outcome measure of cognition, neurological evaluation and neurosensory (visual and auditory) impairment at age two years. NDI is determined on the basis of cognitive score, neurological assessment and the presence of visual and/or auditory impairments (Table 1). If the cognitive score falls within 1 SD of the mean and no abnormalities are found on neurological and sensory examination, NDI is not present. NDI is classified as mildly abnormal if the child has a cognitive score between -1 and -2 SD or if there is mildly abnormal neurological evaluation (postural, coordination, or tone regulation disorder without a clear classifying diagnosis), mild vision problems (strabismus or refractive abnormalities), or mild hearing loss (but not sufficient to require assistive devices). NDI is classified as moderate to severe in a child with a cognitive score < -2 SD or if there is cerebral palsy or other obvious neurological impairment (ataxia), severe functionally impaired vision (magnifying glass needed or blindness), hearing loss requiring assistive devices (hearing aids) or severe sensorineural hearing loss despite assistive devices.If a Bayley-III-NL cannot be performed, the attending neonatologist and psychologist are asked to estimate cognitive development (no delay, 3-6 months delay or more than 6 months delay), corresponding to an NDI rating of none, mild, moderate to severe. The NDI score is based on the worst determinant in one of the four categories. If children are treated by a rehabilitation clinic due to severe neurodevelopmental disorders, they are classified as moderate to severe NDI in the study.Table 1: Classification NeuroDevelopment Impairment (NDI) based on cognition, neurological examination, vision and hearing divided into normal, mild, moderate and severe retardation.ClassificationCognition (IQ)NeurologyVisionHearingNorm | — |
Secondary
| Measure | Time frame |
|---|---|
| Neurophysiological characteristics of the neonatesDiagnosesPsychomotor outcome | — |
Countries
Netherlands
Contacts
Public ContactL.A. Bok
Máxima MC
Outcome results
None listed