Nadolol for Proliferating Infantile Hemangiomas (NCT01010308) | Clinical Trial Compass
CompletedPhase 2
Nadolol for Proliferating Infantile Hemangiomas
Canada20 participantsStarted 2009-11
Plain-language summary
The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of infancy.
The secondary objective is to assess the feasibility of conducting a randomized controlled trial comparing nadolol with corticosteroids and propranolol.
Who can participate
Age range1 Month – 1 Year
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Intervention Group
* Infants aged 1 month to 1 year of age with head and neck hemangiomas currently causing /or with impending function loss (e.g. vision, airway obstruction, feeding, etc), or hemangiomas currently causing/or with potential for facial disfigurement.
Historical Control Group
* Infants aged 1 month to 1 year of age with head and neck hemangiomas that received treatment with systemic propranolol in the past 2 years
Angiogenesis Marker Control Group
* Infants aged 1 month to 1 year attending dermatology clinic
Exclusion Criteria:
Intervention Group
* Patients with PHACES syndrome (proven) or suspected PHACES (plaque like hemangioma awaiting imaging).
* Children with history of hypersensitivity to beta blockers
* Children with personal history or family history of a first degree relative with asthma
* Children with known renal impairment
* Children with known cardiac conditions which may predispose to heart blocks
* Personal history of hypoglycemia
* Children on medications that may interact with beta blockers
Historical Control Group:
* No digital photography available documenting IHs progression
Angiogenesis Marker Control Group:
* Children with IH
* Children on beta blocker or systemic corticosteroids
What they're measuring
1
Proportion of subjects with at least 75% improvement in the extent of the hemangioma