Status:
TERMINATED
Natural Berry Extract Treatment of Hemangiomas
Lead Sponsor:
Gayle Gordillo
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
National Institutes of Health (NIH)
Conditions:
Hemangioma
Eligibility:
All Genders
1-19 years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
PediaBerry™ is a proprietary blend of powdered berry extracts. Placebo: powdered sugar plus McCormick Color from Nature Food Colors Berry and Sky Blue powdered food color (https://www.mccormick.com/sp...
Eligibility Criteria
Inclusion
- Children with hemangiomas ≤ 4 months and 2 weeks of corrected gestational age
- Hemangioma size ≥ 1 cm diameter
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04020419
Start Date
December 1 2020
End Date
May 24 2023
Last Update
October 23 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
2
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205