Infantile Hemangioma
Conditions
Interventions
None listed
Sponsors
Erasmus University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • IH previously treated either with oral propranolol at a = 2 mg/kg/day dose or with oral atenolol at a = 1 mg/kg/day dose. • Treatment being initiated before the age of 1 year. • IQ estimated > 55 (no moderate to severe intellectual disability) • Sufficient comprehension of the Dutch language by parent(s)/legal guardian(s) to understand the study information and to be able to fill out the Dutch questionnaires. • Sufficient comprehension of the Dutch language by the child to be able to participate in the neuropsychological assessment.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Prematurity (< 37 weeks of gestation) • Dysmaturity (birth weight <2.5 SDS for age) • Complicated neonatal phase with hospitalization • Suspected PHACE syndrome • IH having received other treatment than oral propranolol or atenolol, such as other oral beta-blockers, oral corticosteroids, vincristine, interferon alpha, topical beta blockers, intralesional corticosteroids, imiquimod, rapamycin, laser, surgery, cryotherapy • Documented (neuro-) psychological functioning problems before starting with beta blockers • Use of medication that could affect (neuro-) psychological functioning (including multiple general anesthesia) • Genetic syndromes known to affect cognitive performance • Concomitant or successive use of propranolol and atenolol • Participation to a previous clinical development study or Compassionate Use Program (CUP) with V0400SB Next to this, all other possible confounders compromising neurocognitive function will be recorded at inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wechsler Intelligence Scale for Children-V-NL (WISC-V-NL) Cognitive Proficiency Index (a measure of working memory, attention and processing speed) | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychological outcomes: - WISC-V-NL total intelligence quotient - Rey's Auditory Verbal Learning Test (RAVLT) - Developmental Neuropsychological Assessment-II-NL (NEPSY-II-NL): Visual-Spatial Memory - NEPSY-II-NL: Affect Recognition - NEPSY-II-NL: Narrative Memory Psychological outcomes (parent-reported): - Child Behavioral Checklist (CBCL) - Behavior Rating Inventory of Executive Functioning (BRIEF) - Health Related Quality of Life Questionnaire for Children and Young People and their Parents (KIDSCREEN) - Parental Burden of Raising Children (OBVL) - Questions exploring stress and support experienced during and after treatment of IH Residual IH lesion: - Child-reported Visual Analogue Scale (VAS) - Clinician-reported Visual Analogue Scale (VAS) - Parent-reported Patient and Observer Scar Assessment Scale (POSAS) Patient scale - Clinician-reported Patient and Observer Scar Assessment Scale (POSAS) Observer scale - Clinician-reported Hemangioma Activity Score (HAS) - Clinician-reported checklist of residual lesion characteristics | — |
Contacts
Public ContactMireille Hermans
Erasmus University Medical Center
Outcome results
None listed