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Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma (PROIHSTOP)

18 giugno 2026 aggiornato da: Yi Ji, West China Hospital

Rebound Growth After Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma: A Multicenter Randomized Noninferiority 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a prospective, multicenter, randomized, parallel-group, noninferiority trial designed to evaluate whether abrupt discontinuation of propranolol is noninferior to gradual tapering with respect to rebound growth in infantile hemangioma.

Eligible participants will be patients clinically diagnosed with infantile hemangioma who have received oral propranolol treatment for at least 6 months and meet predefined criteria for treatment discontinuation. The discontinuation criteria include complete or near-complete clinical regression of the lesion, no obvious blood flow on ultrasound, and maintenance of maximal regression for 3 months. Participants will be randomly assigned in a 1:1 ratio to either the abrupt discontinuation group or the gradual tapering group.

Participants in the abrupt discontinuation group will stop propranolol immediately after meeting the predefined discontinuation criteria. Participants in the gradual tapering group will receive half of the original total daily dose for the first 2 weeks, followed by one quarter of the original total daily dose for another 2 weeks, and propranolol will be discontinued in week 5.

All participants will be followed for at least 3 months after propranolol discontinuation. Demographic data, infantile hemangioma characteristics, treatment history, lesion size and color before and after treatment, rebound growth, major rebound growth, adverse events after discontinuation, age at rebound, interval from discontinuation to rebound, treatment after rebound, and parental satisfaction will be collected. Rebound growth will be assessed using standardized photographs and/or ultrasound by blinded outcome assessors.

The primary outcome is the proportion of participants with rebound growth after propranolol discontinuation. Rebound growth is defined as more than 20% regrowth in the external appearance of the infantile hemangioma, including changes in color and/or volume. Secondary outcomes include the proportion of participants with major rebound growth, age at rebound, time from discontinuation to rebound, treatment after rebound, adverse events after discontinuation, and parental satisfaction. Major rebound growth is defined as rebound growth requiring modification of oral propranolol treatment, including dose adjustment or restarting propranolol.

The planned sample size is 110 participants, with 55 participants in each group, allowing for an anticipated loss to follow-up rate.

Tipo di studio

Interventistico

Iscrizione (Stimato)

110

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Sichuan
      • Chengdu, Sichuan, Cina, 610041
        • West China Hospital of Sichuan University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Abrupt Discontinuation Group
Participants assigned to this group will discontinue propranolol abruptly after meeting predefined discontinuation criteria for infantile hemangioma.
Droga: Abrupt Discontinuation of Propranolol
Propranolol will be stopped immediately once the participant meets predefined discontinuation criteria, including complete or near-complete clinical regression, no obvious blood flow on ultrasound, and maintenance of maximal regression for 3 months.
Comparatore attivo: Gradual Tapering Group
Participants assigned to this group will undergo gradual tapering of propranolol before complete discontinuation after meeting predefined discontinuation criteria for infantile hemangioma.
Droga: Gradual Tapering of Propranolol
The propranolol dose will be reduced to half of the original total daily dose for the first 2 weeks, then reduced to one quarter of the original total daily dose for another 2 weeks, and propranolol will be discontinued in week 5.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Rebound Growth Following Propranolol Discontinuation
Lasso di tempo: Up to 3 months after complete discontinuation of propranolol
Rebound growth is defined as a greater than 20% increase in the visible extent of the infantile hemangioma after propranolol has been stopped, including change in color and/or volume. Rebound growth will be assessed by blinded outcome assessors using standardized clinical photographs and/or ultrasound.
Up to 3 months after complete discontinuation of propranolol

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Rebound Growth
Lasso di tempo: Up to 3 months after complete discontinuation of propranolol
Time to rebound growth will be defined as the interval from complete discontinuation of propranolol to the first documented evidence of rebound growth.
Up to 3 months after complete discontinuation of propranolol
Age at Rebound Growth
Lasso di tempo: Up to 3 months after complete discontinuation of propranolol
Age at rebound growth will be recorded as the participant's age at the first documented evidence of rebound growth.
Up to 3 months after complete discontinuation of propranolol
Post-Rebound Treatment
Lasso di tempo: Up to 3 months after complete discontinuation of propranolol
Treatment after rebound growth will be recorded, including observation, propranolol dose adjustment, reinitiation of propranolol, topical therapy, laser therapy, surgery, or other treatment.
Up to 3 months after complete discontinuation of propranolol
Incidence of Clinically Significant Rebound Growth
Lasso di tempo: Up to 3 months after complete discontinuation of propranolol
Clinically significant rebound growth is defined as rebound growth that leads to a change in oral propranolol management, including dose adjustment or reinitiation of propranolol.
Up to 3 months after complete discontinuation of propranolol

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

West China Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

30 dicembre 2027

Completamento dello studio (Stimato)

30 marzo 2028

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RCT20260618

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be publicly shared because the dataset includes sensitive pediatric clinical information, clinical photographs, and ultrasound data. De-identified aggregate data may be made available from the principal investigator upon reasonable request and with appropriate ethical approval.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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