Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma
ConditionInfantile Hemangioma (IH)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-60
SponsorWest China Hospital
About this trial
Infantile hemangioma is the most common benign vascular tumor in infancy. Oral propranolol is the first-line systemic treatment for infantile hemangiomas requiring therapy. Although most patients respond well to propranolol, rebound growth may occur after treatment discontinuation, and some patients may require restarting propranolol or receiving additional treatment. In clinical practice, propranolol may be discontinued abruptly after the lesion meets discontinuation criteria, or gradually tapered over several weeks before complete discontinuation. However, high-quality randomized evidence comparing these two discontinuation strategies remains limited.
This multicenter randomized noninferiority trial aims to compare the risk of rebound growth after abrupt discontinuation versus gradual tapering of propranolol in patients with infantile hemangioma who have received oral propranolol for at least 6 months and meet predefined discontinuation criteria.
Eligibility criteria
Qualifiers
Children with a clinical diagnosis of infantile hemangioma.
Complete pretreatment clinical documentation is available, including clinical photographs and/or ultrasound findings.
The child has received oral propranolol for at least 6 months.
The infantile hemangioma meets the predefined criteria for propranolol discontinuation, defined as complete or near-complete clinical regression, no obvious residual blood flow on ultrasound, and stable maximal regression for 3 months.
Disqualifiers
Airway or hepatic infantile hemangiomas, or other high-risk lesions for which rebound growth could rapidly compromise life or vital organ function.
Use of propranolol for arrhythmia, hypertension, or another cardiovascular indication.
A history of rebound growth after prior discontinuation of propranolol.
Laser therapy, sclerotherapy, surgery, systemic corticosteroids, or other systemic treatment within 3 months before randomization.
Trial design
Treatments tested in this trial
- Abrupt Discontinuation of Propranolol
- Gradual Tapering of Propranolol
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov