The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma

Phase 4CompletedNCT01908972

Seoul National University Hospital34 enrolled

Overview

The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.

* Randomized (A group : propranolol, B group : prednisolone) * A group : 3 days admission and medication for 16 weeks * B group : medication for 16 weeks without admission * Hemangioma volume comparison by using MRI * other measurement and drug adverse reaction monitoring

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hemangioma

Interventions

PrednisoloneDRUG

2mg/kg/day for 16weeks

PropranololDRUG

2mg/kg/day for 16weeks

Eligibility

Sex: ALLMax age: 9 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Hemangioma patient ( 0 \~ 9 months old) * No treatment before * 10 \~ 20 % volume increase in 2 \~ 4 weeks * Hemangioma that caused organ function * Hemangioma that will cause aesthetic problem Exclusion Criteria: * Cardiovascular disease (impossible to use propranolol) * Drug adverse reaction or allergy history (propranolol, steroid) * Bradycardia, Atrioventricular block, atrial block * Cardiogenic Shock * Right heart failure (pulmonary hypertension) * Congestive heart failure * Hypotension * Peripheral nerve disease (moderate) * Angina * Hormone deficiency patient * Pulmonary disease (asthma) * diabetic ketoacidosis * laser treatment history

Locations (1)

Seould National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO

The primary efficacy variable was the clinical response at 16 weeks, classified as follows: when the volume did not increase or decreased by less than 25% after treatment began, we defined it as stop of progression; when the volume decreased by 25% or more compared with the original size, we defined it as regression. Both stop of progression and regressionwere defined as reaction. If the volume at the primary efficacy evaluation point was greater than the size measured when treatment started,we called it an increase. Increase was defined as a nonreaction.

Time frame: After 16weeks

Secondary Outcomes

Percent Reduction in Hemangioma Volume From Baseline

Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks))

Time frame: After 16 weeks

Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks

Number of Participants in which, the Heart rate fell to \<70% of acceptable age related minimum post-dose with child awake, anytime during the 16 weeks Count of patients whose Heart rate fall to \<70% of acceptable age related minimum post-dose with child awake

Time frame: up to 16weeks

Number of Participants With Change in Color as Compared to Baseline

Participants were observed for any change in color. The possible change in colors included change to Red/Purple/Blue/Gray/Apricot. Reported are the number of participants who experienced a change in color by the type of color

Time frame: After 16 weeks

Number of Participants With Size Reduction of Ulceration

size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication)

Data from ClinicalTrials.gov

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