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Completed

NCT Number: NCT01908972

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

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

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Key information

Conditions

Hemangioma Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

Up to 9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seould National University Hospital

Seoul, 110-744, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

Drug

2mg/kg/day for 16weeks

Other names: steroid

Propranolol

Drug

2mg/kg/day for 16weeks

Other names: beta-blocker

Primary outcomes

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

    Time frame: 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 outcomes

  1. Percent Reduction in Hemangioma Volume From Baseline

    Time frame: After 16 weeks

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

  2. 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

    Time frame: 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

  3. Number of Participants With Change in Color as Compared to Baseline

    Time frame: 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

  4. Number of Participants With Size Reduction of Ulceration

    Time frame: After 16 weeks

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

  5. Number of Participants With Reepithelialzation in 16weeks

    Time frame: After 16 weeks

    Number of participants with Reepithelialzation in 16weeks..

  6. Number of Participants With Stop of Proliferation

    Time frame: After 16 weeks

    Number of participants whose hemangioma stop proliferating in 16weeks

  7. Number of Participants With Regression

    Time frame: Within 16 weeks

    Number of participants whose hemangioma showed regression in 16 weeks.

  8. Number of Participants With Drug Compliance Within 16 Weeks

    Time frame: After 16 weeks

    We checked Number of participants with Drug compliance within 16 weeks

  9. Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks

    Time frame: 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..

  10. Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks

    Time frame: up to 16weeks

    Number of Participants in Which, Glucose levels fall (to <50mg/dl), Anytime During the 16 Weeks..

  11. Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks

    Time frame: up to 16weeks

    Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks..

  12. Number of Participants With Growth Retardation Within 16 Weeks

    Time frame: up to 16weeks

    Number of Participants with Growth Retardation within 16 weeks..

  13. Number of Participants With Gastroesophageal Reflux Within 16 Weeks

    Time frame: up to 16weeks

    Number of Participants With Gastroesophageal reflux within 16 weeks..

  14. Number of Participants With Adverse Drug Reaction

    Time frame: up to 16weeks

    All symptoms associated adverse drug reaction will be checked

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 26, 2013
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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