Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Alarming hemangioma (s) (complicated forms or localization at risk)
- •Cardiac pathology (cardiac malformation, heart failure, cardiac arrhythmias, pulmonary hypertension)
- •Bronchopulmonary dysplasia
- •Bronchiolitis
- •Raynaud syndrome
- •Phéochromocytoma
- •Development of serious form of hemangioma (bleeding, necrosis, ulceration, infection, respiratory distress) requiring standard treatment
研究组 & 干预措施
2
30-days placebo treatment
干预措施: placebo treatment (Drug)
1
30-days propranolol treatment
干预措施: propranolol treatment (Drug)
结局指标
主要结局
Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.
时间窗: 30 days treatment
次要结局
- 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)