Overview

Comparative Study to Evaluate the Effectiveness of Atenolol and Propranolol in the Treatment of Infantile Hemangiomas

Status:
Unknown status

Trial end date:
2018-12-01

Target enrollment:
0

Participant gender:
All

Summary

Through this study, the investigators shall compare the effectiveness of atenolol with propranolol in the treatment of IH. In addition, the investigators shall try to elucidate the mechanism of action of beta blockers by assessing their action on triggers such as hypoxia. The study design will be a parallel group comparative study wherein patients of IH will be randomized into two groups. One group will receive propranolol and the other atenolol for a maximum period of 9 months. The patients will then be followed up regularly for regression of the IH based on Physician global assessment, hemangioma activity score(HAS), serial photography and lesional ultrasonography. Any side effects encountered during the treatment period will also be noted. Also serial measurements of hypoxia inducible factor 1 alpha(HIF-1α) will be made to ascertain the mechanism of action of the drugs.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Postgraduate Institute of Medical Education and Research

Treatments:

Atenolol
Propranolol

Criteria

Inclusion Criteria:

1. Children diagnosed with problematic infantile hemangiomas

1. Potentially disfiguring infantile hemangiomas at any site.

2. Functionally threatening infantile hemangiomas near the eyes, nose, natural
orifices, limbs, genitalia.

3. Ulcerated infantile hemangiomas.

4. Segmental infantile hemangiomas.

5. Uncomplicated progressive infantile hemangiomas with unpredictable future course.

2. Age group: less than 1 year of age.

3. Either sex

4. Multiple hemangiomas

Exclusion Criteria:

1. Infants with heart disease, cardiac arrhythmias

2. Broncho -obstructive disease.

3. Premature infants with corrected age less than 40 weeks.

4. Known hypoglycemia

5. Diabetes mellitus

6. Hypertension

7. Hypotension

8. Liver failure

9. Visceral hemangiomas

10. PHACES syndrome