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

2026년 6월 18일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

110

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Sichuan
      • Chengdu, Sichuan, 중국, 610041
        • West China Hospital of Sichuan University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Abrupt Discontinuation Group
Participants assigned to this group will discontinue propranolol abruptly after meeting predefined discontinuation criteria for infantile hemangioma.
의약품: 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.
활성 비교기: 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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Rebound Growth Following Propranolol Discontinuation
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Time to Rebound Growth
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

West China Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2027년 12월 30일

연구 완료 (추정된)

2028년 3월 30일

연구 등록 날짜

최초 제출

2026년 6월 18일

QC 기준을 충족하는 최초 제출

2026년 6월 18일

처음 게시됨 (실제)

2026년 6월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 18일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RCT20260618

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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