Natural Berry Extract Treatment of Hemangiomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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/spices-and-flavors/extracts-and-food-colors/food-colors/color-from-nature-assorted-food-color ). Cream vehicle is mixed with PediaBerry™ or placebo at the time of application.Children will receive once daily topical and oral gavage dosing of PediaBerry or placebo. The first study visit will take place within 2 weeks of subject recruitment. The subject enrollment, consenting and randomization will occur as study visit #0 and will occur at Riley Children's Hospital or Nationwide Children's Hospital. Data collection will be the same at all study visits starting with study visit #1 until the completion of the study. The first dose of PediaBerry™ or placebo will be administered prior to completion of study visit #1, and will also be given at study visits #2-6. Study visits #2-6 will occur monthly study visits until the subject completes 6 months of treatment.Subjects will be weighed and treatment doses adjusted accordingly. Study visits #7-11 to watch for signs of rebound hemangioma proliferation will occur every other month until age 12 months and then at age 15 and 18 months. Urine samples, photos and caliper measurements will occur at each study visit. Some subjects may have less than 11 study visits depending on the age at the time of subject enrollment.

Official Title
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Natural Berry Extract Treatment of Hemangiomas

Conditions
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Hemangioma

Intervention / Treatment
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* Drug: PediaBerry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 19 Weeks

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pilot study to determine effect size for possible FDA phase I/II trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediaberry group<br>PediaBerry™ is a proprietary blend powdered berry extracts | Drug: PediaBerry<br>* PediaBerry or placebo will be mixed with a cream vehicle for topical administration or with water for oral administration<br>* Other names: placebo;|
| Placebo Comparator: Placebo<br>Placebo: powdered sugar plus McCormick Color from Nature Food Colors Berry and Sky Blue powdered food color (https://www.mccormick.com/spices-and-flavors/extracts-and-food-colors/food-colors/color-from-nature-assorted-food-color ). | Drug: PediaBerry<br>* PediaBerry or placebo will be mixed with a cream vehicle for topical administration or with water for oral administration<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased Hemangioma Size | Decrease in the size of hemangioma > 50% | 6 month treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased urinary micro RNA 126 levels | Urinary micro RNA 126 levels are analyzed using quantitative polymerase chain reactions | 6 month treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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miR126, Pediaberry