''Efficacy of Propranolol in the Treatment of Infantile Hemangioma

Study Overview
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Brief Summary
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''Evaluation of the Efficacy of Propranolol in the Treatment of Infantile Hemangioma

Detailed Description
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Infantile hemangiomas (IH) are benign tumors of vascular endothelium.They are the most common tumors of infancy. They occur in about 4% of infants, though early studies were as high as 10%, probably due to the inclusion of other vascular lesions. The incidence is higher in premature infants, Caucasians, and females (by a 3 to 5:1 ratio). Advanced maternal age, multiple gestations, and placental abnormalities are also risk factors. IHs have a unique and characteristic life cycle consisting of three phases: proliferative, involuting, and involuted. The majority of IHs do not require any specific treatment other than observation and reassurance of the parents. Even tumors that exhibit rapid growth or fiery red skin will spontaneously regress and leave behind little to no evidence of their presence. However, regular follow-up is important as the potential complications have few clinical indicators. Reasons for treatment include dangerous locations (impinging on a vital structure such as the airway or eye), unusually large size or rapid growth, and local or endangering complications (skin ulceration or high-output heart failure). Hemangiomas exhibiting the aforementioned risk factors or complications should be considered for treatment. As hemangiomas are tumors of pure angiogenesis, pharmacologic therapy involves angiogenesis inhibition. Historically, steroids have been used as the primary treatment for IH. Steroids have been shown to be antiangiogenic in a number of in vitro settings and also have shown good therapeutic effects clinically. However, the use of steroids may lead to various complications including gastroesophageal reflux and growth disorders, although these complications are associated with long-term use and high dose. A type of anticancer drug or immunomodulator, interferon alfa, may be used for severe IH in cases where patients did not respond to steroids. However, interferon alfa also has several possible adverse effects, including fever, muscle pain, systemic myalgia, and in severe cases, liver damage, blood toxic effects, thyroid hormonal abnormality, and neurological and neurodevelopmental toxic effects. Because of concerns about these adverse effects, many guardians of pediatric patients prefer to wait rather than accept treatment. Propranolol, a nonselective beta blocker, has recently been recognized as an important treatment option for hemangiomas. In most centers, it has become first-line pharmacotherapy. A child with a nasal capillary hemangioma treated with propranolol for steroid-induced cardiomyopathy had regression of his lesion. This revelation led to the publication of several more studies supporting this finding. Propranolol is given orally at 2-3 mg/kg/day, in two or three divided doses, and discontinued following regression of the lesion. Treatment often leads to a consistent, rapid, therapeutic effect with softening of the lesion on palpation and color shift from intense red to purple. Propranolol is well tolerated but can cause rare side effects such as bradycardia, gastroesophageal reflux, hypoglycemia, hypotension, rash, somnolence, and wheezing.

Official Title
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'' Efficacy of Propranolol in the Treatment of Infantile Hemangioma

Conditions
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Infantile Hemangioma

Intervention / Treatment
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* Drug: Propranolol Therapy for Infantile Hemangioma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children diagnosed with problematic infantile hemangiomas: A-Large hemangiomas at increased risk of scarring or disfigurement at any site. B-Hemangiomas carrying functional risks near the eyes, nose, natural orifices, limbs, genitalia. C-Ulcerated infantile hemangiomas. D-Uncomplicated progressive infantile hemangiomas with unpredictable future course. E-Life-threatening hemangiomas. Multiple hemangiomas Exclusion Criteria: Patients older than 1 year of age. Patients with heart diseases. Patients with history of bronchspasm or wheezing. Patients with Hypotension. Patients with Hypertension. Premature infants with corrected age less than 5 weeks. Patients with conditions affecting blood glucose maintenance. Patients with liver failure. Patients with PHACES syndrome.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This study will involve patients with infantile hemangiomas who will be admitted at the Assiut University Children Hospital between January 2021 and December 2021.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Propranolol Therapy<br>This arm will involve patients with infantile hemangiomas who will be admitted at the Assiut University Children Hospital between January 2021 and December 2021. | Drug: Propranolol Therapy for Infantile Hemangioma<br>* If there are no contraindications to propranolol, it will be given at initial dose of 0.5 mg /kg/day in 2-3 divided doses with feeds and the patients will be observed for clinical signs of serious adverse reactions. If the dose is tolerated, it will be maintained for four to seven days, and then it will be increased by 0.5mg/kg/day every four days to the target dose of 2mg/kg/day. The patients will be observed for 2 hours after each dose increase for the clinical signs of severe side effects.<br>* Other names: Propranolol Treatment for Infantile Hemangioma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clinical clearance of hemangioma or reduction of hemangioma's volume. | The efficacy of the treatment will be evaluated by complete clinical clearance of lesion (defined arbitrarily as >90% reduction in the size of Infantile Hemangioma as assessed by Physician Global Assessment) or after 9 months of treatment (primary end point) whichever is earlier for cutaneous infantile hemangiomas and by volume reduction of hemangiomas as evaluated by the proper imaging modalities ( Ultrasound, CT, or MRI) for non cutaneous hemangiomas. | within 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemangioma, Propranolol, Beta Blockers