Neoplasms

All Conditions

Hemangioma

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Propranolol

Prednisolone

Methylprednisolone

Adrenergic beta-Antagonists

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Kyung-Duk Park, MD, Ph D

Tae Hyun Choi, MD, Ph D

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

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

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.

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 Count of patients whose Heart rate fall to \<70% of acceptable age related minimum post-dose with child awake

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

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..

Number of participants whose hemangioma stop proliferating in 16weeks

Number of participants whose hemangioma showed regression in 16 weeks.

We checked Number of participants with Drug compliance within 16 weeks

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 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..

Number of Participants with Growth Retardation within 16 weeks..

Number of Participants With Gastroesophageal reflux within 16 weeks..

All symptoms associated adverse drug reaction will be checked

Seoul National University Hospital

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

South Korea

Region of Enrollment

Hemangioma volume by MRI

Although the sample size in the present study was predetermined to show noninferiority, it is difficult to provide strong evidence of safety outcomes.

The present study was not a double-blind trial.

Spots Global Cancer Trial Database for The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma

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