Comparative Study to Evaluate the Effectiveness of Atenolol and Propranolol in the Treatment of Infantile Hemangiomas
Infantile Hemangioma
About this trial
This is an interventional treatment trial for Infantile Hemangioma
Eligibility Criteria
Inclusion Criteria:
Children diagnosed with problematic infantile hemangiomas
- Potentially disfiguring infantile hemangiomas at any site.
- Functionally threatening infantile hemangiomas near the eyes, nose, natural orifices, limbs, genitalia.
- Ulcerated infantile hemangiomas.
- Segmental infantile hemangiomas.
- Uncomplicated progressive infantile hemangiomas with unpredictable future course.
- Age group: less than 1 year of age.
- Either sex
- Multiple hemangiomas
Exclusion Criteria:
- Infants with heart disease, cardiac arrhythmias
- Broncho -obstructive disease.
- Premature infants with corrected age less than 40 weeks.
- Known hypoglycemia
- Diabetes mellitus
- Hypertension
- Hypotension
- Liver failure
- Visceral hemangiomas
- PHACES syndrome
Sites / Locations
- PGIMERRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Group A- Propranolol
Group B- Atenolol
Oral propranolol 1mg/kg/day as crushed tablets, in two divided doses, increased to 2mg/kg/day in two divided doses after 24 hours if tolerated well. Treatment will be stopped at 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.
Oral atenolol 0.5mg/kg as a single dose, increased to 1mg/kg as a single dose after 24 hours if tolerated well. Treatment will be stopped at 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.