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Clinical Trials/NL-OMON29448
NL-OMON29448
Completed
Not Applicable

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

Erasmus University Medical Center0 sites108 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

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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