europsychological functioning and behavior of children previously treated with propranolol or atenolol for infantile hemangioma

Erasmus University Medical Center0 个研究点目标入组 108 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•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.

•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.

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