Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2009-11-30
2012-02-29
Brief Summary
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The secondary objective is to assess the feasibility of conducting a randomized controlled trial comparing nadolol with corticosteroids and propranolol.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention Group:
The patients in this study are 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
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 as a control group
Nadolol
Nadolol will be administered orally at home starting at 0.5 mg/kg/day divided into 2 doses. Weekly, if BP and heart rate are acceptable, the dose will be increased by 0.5 mg/kg/day up to 2 mg/kg/day.
Historical control group
Ten infants (1-12 months of age) treated with propranolol will be identified from a Dermatology Database. Patients will be considered as controls if they were treated with propranolol before 1 year of age and had digital photography documentation of their hemangioma.
No interventions assigned to this group
Angiogenesis marker control group
The angiogenesis marker control group will consist of 6 -10 patients seen in the Dermatology clinic for conditions other than IH and not receiving corticosteroids or beta blockers.
No interventions assigned to this group
Interventions
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Nadolol
Nadolol will be administered orally at home starting at 0.5 mg/kg/day divided into 2 doses. Weekly, if BP and heart rate are acceptable, the dose will be increased by 0.5 mg/kg/day up to 2 mg/kg/day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Month
1 Year
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Elena Pope
Staff Physician
Principal Investigators
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Elena Pope, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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1000014079
Identifier Type: -
Identifier Source: org_study_id
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