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Trial record 8 of 21 for:    PROPRANOLOL AND Infantile Hemangioma

Propranolol in Capillary Hemangiomas (HEMANGIOMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00744185
Recruitment Status : Terminated (Study halted prematurely due to some difficulties in recruitment of patients)
First Posted : August 29, 2008
Last Update Posted : July 19, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE August 28, 2008
First Posted Date  ICMJE August 29, 2008
Last Update Posted Date July 19, 2012
Study Start Date  ICMJE October 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2008)
Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment. [ Time Frame: 30 days treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00744185 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2008)
  • Proportion of hemangioma size variation measured clinically and with photography from the basal state between the two groups after 1 month-treatment. [ Time Frame: 30 days-treatment ]
  • Observance [ Time Frame: 30 days-treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Propranolol in Capillary Hemangiomas
Official Title  ICMJE Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas
Brief Summary

The investigators observed that Propranolol, a beta-blocker commonly used in children was efficient to control the growth of alarming hemangiomas of the face.

The primary objective of this study is to determine the efficiency of 1 month-early treatment of propranolol in infants aged less than 4 months affected by an hemangioma without any consequences on vital or functional structure and not justifying corticosteroids.

The secondary objectives are:

  • the kinetic of the hemangioma evolution in infants treated by propranolol
  • Observance
  • Safety
Detailed Description

Infantile hemangiomas are frequent vascular tumors (4 à 10 % of the neonates) and correspond to 100 new cases per year in dermatology consultation of the CHU of Bordeaux. Hemangiomas have a characteristic clinical course marked by early proliferation during 3 to 12 months followed by slow and spontaneous involution from 3 to 7 years. Occasionally, as well as esthetical damages, hemangiomas may impair vital structures, ulcerate, bleed, or cause high-output cardiac failure or significant structural abnormalities. Standard treatments (corticotherapy, interferon, vincristine…) lead to a stagnation of hemangiomas in some cases, but with frequent side effects.

We observed that Propranolol, a beta-blocker usually used in neonates could lead to a decreased in volume of serious haemangiomas of the face (article published in New England Journal of Medicine).

In this study, we proposed to determine the efficiency of 1 month-early treatment of propranolol in neonates aged less than 4 months affected by non alarming hemangioma and not justifying corticotherapy. This is a double blind randomized placebo controlled study of propranolol.

Infants will be recruited from the dermatology consultation of CHU Bordeaux. After verification of eligibility criteria and informed consent of legal surrogates, infants will be randomized to receive either propranolol or either placebo. The infants will be observed during 1 month according to the following visits.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hemangioma, Capillary
Intervention  ICMJE
  • Drug: propranolol treatment
    30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
  • Drug: placebo treatment
    30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
Study Arms  ICMJE
  • Placebo Comparator: 2
    30-days placebo treatment
    Intervention: Drug: placebo treatment
  • Experimental: 1
    30-days propranolol treatment
    Intervention: Drug: propranolol treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 1, 2011)
14
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2008)
50
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infant aged less than 4 months
  • Infant with one or more hemangiomas sized more than 1 cm diameter
  • Infant not threatening for vital or functional structure and for which no treatment would be proposed
  • Informed consent
  • Patient with social insurance.

Exclusion Criteria:

  • Alarming hemangioma (s) (complicated forms or localization at risk)
  • Cardiac pathology (cardiac malformation, heart failure, cardiac arrhythmias, pulmonary hypertension)
  • Asthma
  • Bronchopulmonary dysplasia
  • Bronchiolitis
  • Raynaud syndrome
  • Phéochromocytoma
  • Development of serious form of hemangioma (bleeding, necrosis, ulceration, infection, respiratory distress) requiring standard treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 4 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00744185
Other Study ID Numbers  ICMJE CHUBX 2007/27
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nicholas Moore, Professor University Hospital Bordeaux, France
PRS Account University Hospital, Bordeaux
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP