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
72 participants
OBSERVATIONAL
2008-08-31
2013-10-31
Brief Summary
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This observational study was undertaken in an uncontrolled fashion to determine sample size, design and and tools for a later randomized controlled trial on propranolol versus physical therapy (i.e.cryotherapy) which is the most prevalent treatment for the condition. During this initial series side effects and relevant design aspects became evident which warrant expedited reporting.
Detailed Description
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Surveillance and adverse event (AE) reporting:
Pretreatment monitoring included a 24 hr ECG (in KKB a 2 minute rhythm strip), pulse, blood pressure, fasting blood glucose and echocardiography. All patients were kept at a cardiac monitor. Blood pressure was monitored 6 hourly and blood glucose was assayed twice with each new dose at one hour after drug ingestion. If the patient has had 3 full doses the investigators repeated the 24 hr ECG and the echocardiography. Bradycardia and Hypotension events were defined according to the age dependent standards , Side effects/adverse events were defined according to ICH guidelines and screened for as events leading to either a physician contract and a medical measure (dose reduction, ß-mimetic or other medication).
Lesion evaluation:
Hemangioma size was measured with calipers before and after the completed therapy at the end of the 8th month of life. Thickness was checked with a 7.5 mHz linear array pediatric probe.
For evaluation of their cosmesis the lesions were documented with 2 photos each (white balanced flash and ambiance light) before and after treatment (standardized to 30 cm distance, circa 2 Mb resolution). Images were shown at the same week to 3 examiners being unaware whether images were taken pre- or post treatment. This was repeated twice at two weeks interval. As there is no validated hemangioma specific assessment tool a rating form was compiled in an expert discussion from validated scar and burns scales: Categorical items included "Vascularity" and "Height" from the Vancouver Scar Scale , "Irregularity" from the Hamilton burn scar rating form for photographic analysis and the "matte/shiny" classification from the Manchester Scar Scale . A 10 cm plastic surgery visual analogue scale provided non-categorical data on overall appearance.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Threatening hemangioma
The group with cosmetically threatening of functionally threatening hemangiomas warranting active treatment according to our usual criteria (location face, hands, feet with a strong growth tendency and below age of 8 months)
Propranolol
Propranolol 2mg/kg/day divided to three oral doses with or without concomitant physical therapy (cryotherapy, laser)
Interventions
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Propranolol
Propranolol 2mg/kg/day divided to three oral doses with or without concomitant physical therapy (cryotherapy, laser)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Month
8 Months
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Carsten Engelmann
Oberarzt
Principal Investigators
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Carsten R Engelmann, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Benno M Ure, Prof.
Role: STUDY_DIRECTOR
Hannover Medical School
Locations
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Pediatric Surgery, Kinderkrankenhaus Bult
Hanover, Hannover, Germany
Pediatric Surgery, Hannover Medical School
Hanover, Lower Saxony, Germany
Kinderzentrum Klinikum Hildesheim
Hildesheim, Lower Saxony, Germany
Countries
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References
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Holland KE, Frieden IJ, Frommelt PC, Mancini AJ, Wyatt D, Drolet BA. Hypoglycemia in children taking propranolol for the treatment of infantile hemangioma. Arch Dermatol. 2010 Jul;146(7):775-8. doi: 10.1001/archdermatol.2010.158.
Related Links
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university web site/english
Other Identifiers
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AB 3
Identifier Type: -
Identifier Source: org_study_id