NL-OMON29448
Completed
Not Applicable
europsychological functioning and behavior of children previously treated with propranolol or atenolol for infantile hemangioma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus University Medical Center
- Enrollment
- 108
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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