Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma (PROIHSTOP)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Yi Ji, MD, PhD
- Telefonní číslo: 862885423453
- E-mail: jijiyuanyuan@163.com
Studijní místa
-
-
Sichuan
-
Chengdu, Sichuan, Čína, 610041
- West China Hospital of Sichuan University
-
Kontakt:
- Yi Ji, MD PhD
- Telefonní číslo: +862885423453
- E-mail: jijiyuanyuan@163.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
- Written informed consent is provided by a parent or legal guardian.
- The parent or legal guardian is able and willing to complete the scheduled follow-up assessments.
Exclusion Criteria:
- 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.
- Severe cardiac, respiratory, hepatic, renal, metabolic, or other systemic disease that may affect participant safety or study assessment.
- Inability to complete standardized photography, ultrasound assessment, or scheduled follow-up.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Abrupt Discontinuation Group
Participants assigned to this group will discontinue propranolol abruptly after meeting predefined discontinuation criteria for infantile hemangioma.
|
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.
|
|
Aktivní komparátor: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of Rebound Growth Following Propranolol Discontinuation
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to Rebound Growth
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RCT20260618
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .