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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000202-36 | EudraCT Number |
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Study halted prematurely due to some difficulties in recruitment of patients
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | 30-days placebo treatment |
|
| 1 | Experimental | 30-days propranolol treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propranolol treatment | Drug | 30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment. | 30 days treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of hemangioma size variation measured clinically and with photography from the basal state between the two groups after 1 month-treatment. | 30 days-treatment | |
| Observance | 30 days-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Moore, Professor | University Hospital Bordeaux, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologie Pédiatrique | Bordeaux | 33 076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18550886 | Background | Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available. | |
| 14583354 | Background | Tortoriello TA, Snyder CS, Smith EO, Fenrich AL Jr, Friedman RA, Kertesz NJ. Frequency of recurrence among infants with supraventricular tachycardia and comparison of recurrence rates among those with and without preexcitation and among those with and without response to digoxin and/or propranolol therapy. Am J Cardiol. 2003 Nov 1;92(9):1045-9. doi: 10.1016/j.amjcard.2003.06.002. |
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| ID | Term |
|---|---|
| D018324 | Hemangioma, Capillary |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| placebo treatment |
| Drug |
30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days |
|
| 15321698 | Background | Villain E, Denjoy I, Lupoglazoff JM, Guicheney P, Hainque B, Lucet V, Bonnet D. Low incidence of cardiac events with beta-blocking therapy in children with long QT syndrome. Eur Heart J. 2004 Aug;25(16):1405-11. doi: 10.1016/j.ehj.2004.06.016. |
| 12661740 | Background | Kilian K. Hypertension in neonates causes and treatments. J Perinat Neonatal Nurs. 2003 Jan-Mar;17(1):65-74; quiz 75-6. doi: 10.1097/00005237-200301000-00006. |
| 9527943 | Background | Fritz KI, Bhat AM. Effect of beta-blockade on symptomatic dexamethasone-induced hypertrophic obstructive cardiomyopathy in premature infants: three case reports and literature review. J Perinatol. 1998 Jan-Feb;18(1):38-44. |
| 23301692 | Result | Leaute-Labreze C, Dumas de la Roque E, Nacka F, Abouelfath A, Grenier N, Rebola M, Ezzedine K, Moore N. Double-blind randomized pilot trial evaluating the efficacy of oral propranolol on infantile haemangiomas in infants < 4 months of age. Br J Dermatol. 2013 Jul;169(1):181-3. doi: 10.1111/bjd.12217. No abstract available. |
| 26813215 | Result | Prey S, Voisard JJ, Delarue A, Lebbe G, Taieb A, Leaute-Labreze C, Ezzedine K. Safety of Propranolol Therapy for Severe Infantile Hemangioma. JAMA. 2016 Jan 26;315(4):413-5. doi: 10.1001/jama.2015.13969. No abstract available. |
| 29571951 | Result | Boccara O, Maruani A, Leaute-Labreze C. [Benign aggressive vascular anomalies in children]. Bull Cancer. 2018 Jun;105(6):610-625. doi: 10.1016/j.bulcan.2018.01.016. Epub 2018 Mar 20. French. |