Natural Berry Extract Treatment of Hemangiomas

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment of hemangiomas in infants ≤ 4 months of corrected gestation age over a 6-month treatment period. Subjects will be followed to age 18 months. A total of 44 subjects will be PediaBerry group and 22 subjects in the placebo control group.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborators: National Institute of General Medical Sciences (NIGMS); National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• Children with hemangiomas ≤ 4 months and 2 weeks of corrected gestational age

• Hemangioma size ≥ 1 cm diameter

Exclusion Criteria:

• Children with hemangiomas that threaten the life of the child or development of vital structures.

• Children who are breast feeding and mother is taking beta blocker medication

• Children with previously treated hemangiomas

• Congenital hemangiomas - cannot distinguish between rapidly involuting and non-involuting congenital hemangiomas

• Hemangiomas located in the perineal/diapering area - product will get contaminated or wiped off with diapering

• Children with food allergies to blueberries or any other kind of berry

• Legal guardian unable to provide informed consent