Phase 4
N=34
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
Hemangioma
Bottom Line
View on ClinicalTrials.gov: NCT01908972 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO — 14; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prednisolone (Drug); Propranolol (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO |
14; 16 | — |
| SECONDARY Percent Reduction in Hemangioma Volume From Baseline |
46.52; 55.87 | — |
| SECONDARY 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 |
1; 5 | — |
| SECONDARY Number of Participants With Change in Color as Compared to Baseline |
13; 14; 0; 0 | — |
| SECONDARY Number of Participants With Size Reduction of Ulceration |
2; 1 | — |
| SECONDARY Number of Participants With Reepithelialzation in 16weeks |
4; 8 | — |
| SECONDARY Number of Participants With Stop of Proliferation |
15; 17 | — |
| SECONDARY Number of Participants With Regression |
9; 13 | — |
| SECONDARY Number of Participants With Drug Compliance Within 16 Weeks |
15; 17 | — |
| SECONDARY Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks |
1; 5 | — |
| SECONDARY Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks |
0; 0 | — |
| SECONDARY Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks |
5; 0 | — |
| SECONDARY Number of Participants With Growth Retardation Within 16 Weeks |
2; 0 | — |
| SECONDARY Number of Participants With Gastroesophageal Reflux Within 16 Weeks |
0; 0 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction |
15; 16 | — |
Summary
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01908972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.