Clinical trial NCT00744185: Propranolol in Capillary Hemangiomas
Official title: Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Hemangioma, Capillary
Keywords: infantile capillary hemangiomas
propranolol
ultrasonography
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2008-08-29
Enrollment: 14
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.
timeFrame: 30 days treatment
Secondary outcomes:
measure: Proportion of hemangioma size variation measured clinically and with photography from the basal state between the two groups after 1 month-treatment.
timeFrame: 30 days-treatment
measure: Observance
timeFrame: 30 days-treatment
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Dermatologie Pédiatrique
Study officials:
affiliation: University Hospital Bordeaux, France
name: Nicholas Moore, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.