Clinical trial · Interventional
Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma
Rebound Growth After Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma: A Multicenter Randomized Noninferiority Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infantile Hemangioma (IH) | Infantile Hemangioma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abrupt Discontinuation of Propranolol | Drug | — | UNRESOLVED |
| Gradual Tapering of Propranolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abrupt Discontinuation Group
- description
- Participants assigned to this group will discontinue propranolol abruptly after meeting predefined discontinuation criteria for infantile hemangioma.
- interventionNames
- Drug: Abrupt Discontinuation of Propranolol
- type
- ACTIVE_COMPARATOR
- label
- Gradual Tapering Group
- description
- Participants assigned to this group will undergo gradual tapering of propranolol before complete discontinuation after meeting predefined discontinuation criteria for infantile hemangioma.
- interventionNames
- Drug: Gradual Tapering of Propranolol
Primary outcomes (1)
- measure
- Incidence of Rebound Growth Following Propranolol Discontinuation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 60 Months
Show eligibility criteria text
Inclusion Criteria: 1. Children with a clinical diagnosis of infantile hemangioma. 2. Complete pretreatment clinical documentation is available, including clinical photographs and/or ultrasound findings. 3. The child has received oral propranolol for at least 6 months. 4. 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. 5. Written informed consent is provided by a parent or legal guardian. 6. The parent or legal guardian is able and willing to complete the scheduled follow-up assessments. Exclusion Criteria: 1. Airway or hepatic infantile hemangiomas, or other high-risk lesions for which rebound growth could rapidly compromise life or vital organ function. 2. Use of propranolol for arrhythmia, hypertension, or another cardiovascular indication. 3. A history of rebound growth after prior discontinuation of propranolol. 4. Laser therapy, sclerotherapy, surgery, systemic corticosteroids, or other systemic treatment within 3 months before randomization. 5. Severe cardiac, respiratory, hepatic, renal, metabolic, or other systemic disease that may affect participant safety or study assessment. 6. Inability to complete standardized photography, ultrasound assessment, or scheduled follow-up.
References
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