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

Phase 4

Completed

• Conditions: Hemangioma
• Interventions: Drug: Prednisolone; Drug: Propranolol

• Registration Number: NCT01908972
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

* 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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-26
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-02
• Results First Submitted: 2017-10-29
• Results First Submitted QC: 2018-01-04
• Results First Posted: 2018-10-26
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone	Prednisolone	Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks
Propranolol	Propranolol	Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO	After 16weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks	up to 16weeks	Number of Participants in Which, the Systolic blood pressure fall of \>25% of baseline postdose with child awake, Anytime During the 16 Weeks..
Number of Participants With Stop of Proliferation	After 16 weeks	Number of participants whose hemangioma stop proliferating in 16weeks
Number of Participants With Regression	Within 16 weeks	Number of participants whose hemangioma showed regression in 16 weeks.
Number of Participants With Drug Compliance Within 16 Weeks	After 16 weeks	We checked Number of participants with Drug compliance within 16 weeks
Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks	up to 16weeks	Number of Participants in Which, Glucose levels fall (to \<50mg/dl), Anytime During the 16 Weeks..
Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks	up to 16weeks	Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks..
Number of Participants With Growth Retardation Within 16 Weeks	up to 16weeks	Number of Participants with Growth Retardation within 16 weeks..
Percent Reduction in Hemangioma Volume From Baseline	After 16 weeks	Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 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	up to 16weeks	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
Number of Participants With Change in Color as Compared to Baseline	After 16 weeks	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
Number of Participants With Size Reduction of Ulceration	After 16 weeks	size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication)
Number of Participants With Reepithelialzation in 16weeks	After 16 weeks	Number of participants with Reepithelialzation in 16weeks..
Number of Participants With Gastroesophageal Reflux Within 16 Weeks	up to 16weeks	Number of Participants With Gastroesophageal reflux within 16 weeks..
Number of Participants With Adverse Drug Reaction	up to 16weeks	All symptoms associated adverse drug reaction will be checked

Trial Locations

Locations (1)

Seould National University Hospital; 🇰🇷 Seoul, Korea, Republic of