Risk Stratification and Treatment Decisions in Infantile Hemangioma With Minimal or Arrested Growth

NCT07669545 | Not Yet Recruiting

• 1 other identifier: RCT20260621
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Infantile hemangioma with minimal or arrested growth (IH-MAG) is a subtype of infantile hemangioma that shows little or no obvious growth during infancy. Although these lesions may appear less active than classic infantile hemangiomas, some may still be associated with ulceration, functional risk, permanent disfigurement, or structural anomalies. This prospective observational cohort study will compare infants with IH-MAG and infants with classic infantile hemangioma at their first specialist evaluation. Each participant will undergo routine clinical assessment, standardized photography, risk classification according to the 2019 American Academy of Pediatrics guideline, and Hemangioma Severity Scale scoring. The main outcome is the initial management recommendation after specialist assessment, categorized as active management or treatment versus observation. The study will not assign any treatment. All management recommendations will be made by clinicians according to routine clinical practice and guideline-based assessment.

Conditions

Infantile Hemangioma (IH)

Keywords

Infantile Hemangioma With Minimal or Arrested Growth; infantile hemangioma

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Recommended for Active Management at the Initial Specialist Evaluation

  The proportion of participants for whom active management is recommended at baseline, defined as the initial specialist evaluation on Day 0. Active management is defined as any recommendation for pharmacologic treatment, procedural treatment, imaging evaluation, specialist referral, or multidisciplinary assessment based on guideline-based risk assessment. Observation is defined as scheduled follow-up, parental education, photographic monitoring, and risk counseling without active treatment or additional active evaluation at baseline.

  Baseline (Day 0)

Secondary Outcomes (3)

• Distribution of 2019 American Academy of Pediatrics Infantile Hemangioma Risk Categories at Baseline

  Baseline (Day 0)

• Hemangioma Severity Scale Total Score at Baseline

  Baseline (Day 0)

• Distribution of Baseline Hemangioma Severity Scale Categories

  Baseline (Day 0)

Study Arms (2)

IH-MAG Cohort

Infants clinically diagnosed with infantile hemangioma with minimal or arrested growth at the first specialist evaluation. IH-MAG is defined as an early-onset vascular lesion with minimal or absent proliferative growth, with proliferative components involving less than 25% of the total lesion area. Participants in this cohort will undergo routine clinical assessment, standardized photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up. No treatment is assigned by the study protocol.

Other: Routine Clinical Assessment and Risk Stratification

Typical Infantile Hemangioma Cohort

Infants clinically diagnosed with typical infantile hemangioma at the first specialist evaluation who do not meet the diagnostic criteria for infantile hemangioma with minimal or arrested growth. This cohort may include superficial, deep, mixed, focal, segmental, or multifocal infantile hemangiomas. Participants will undergo routine clinical assessment, standardized photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up. No treatment is assigned by the study protocol.

Other: Routine Clinical Assessment and Risk Stratification

Interventions

Routine Clinical Assessment and Risk Stratification OTHER

Participants will undergo routine specialist evaluation, standardized clinical photography, AAP risk classification, Hemangioma Severity Scale scoring, and follow-up data collection. Initial management recommendations will be made by clinicians according to routine clinical practice and guideline-based assessment. No treatment is assigned by the study protocol.

IH-MAG Cohort; Typical Infantile Hemangioma Cohort

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants aged 12 months or younger who present for their first systematic evaluation at a hemangioma specialty clinic and are clinically diagnosed with either infantile hemangioma with minimal or arrested growth or classic infantile hemangioma. Participants will be enrolled prospectively and followed as two observational cohorts.

You may qualify if:

• Infants clinically diagnosed with infantile hemangioma, including minimal or arrested growth infantile hemangioma and classic infantile hemangioma.
• Participants undergoing their initial specialist evaluation at the study center.
• Age at baseline: from birth to 24 months.
• Sufficient clinical information available for baseline assessment, including lesion location, morphology, size, number of lesions, complications, and treatment recommendation.
• Parents or legal guardians are able to understand the study procedures and provide written informed consent.

You may not qualify if:

• Patients with vascular anomalies other than infantile hemangioma, including vascular malformations, congenital hemangioma, kaposiform hemangioendothelioma, pyogenic granuloma, or other vascular tumors.
• Patients with insufficient clinical information to determine the infantile hemangioma subtype, AAP risk category, Hemangioma Severity Scale score, or baseline treatment recommendation.
• Patients who have received systemic pharmacologic treatment, procedural treatment, laser therapy, or surgical treatment for infantile hemangioma before the baseline specialist evaluation.
• Patients with severe comorbidities or unstable medical conditions that may interfere with clinical assessment or follow-up.
• Parents or legal guardians who decline participation or are unable to provide informed consent.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (3)

• Suh KY, Frieden IJ. Infantile hemangiomas with minimal or arrested growth: a retrospective case series. Arch Dermatol. 2010 Sep;146(9):971-6. doi: 10.1001/archdermatol.2010.197.

  PMID: 20855695 BACKGROUND

• Haggstrom AN, Beaumont JL, Lai JS, Adams DM, Drolet BA, Frieden IJ, Garzon MC, Holland KE, Horii KA, Lucky AW, Mancini AJ, Metry DW, Morel KD, Newell BD, Nopper AJ, Siegel D, Swigonski NL, Cella D, Chamlin SL. Measuring the severity of infantile hemangiomas: instrument development and reliability. Arch Dermatol. 2012 Feb;148(2):197-202. doi: 10.1001/archdermatol.2011.926.

  PMID: 22351819 BACKGROUND

• Krowchuk DP, Frieden IJ, Mancini AJ, Darrow DH, Blei F, Greene AK, Annam A, Baker CN, Frommelt PC, Hodak A, Pate BM, Pelletier JL, Sandrock D, Weinberg ST, Whelan MA; SUBCOMMITTEE ON THE MANAGEMENT OF INFANTILE HEMANGIOMAS. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. 2019 Jan;143(1):e20183475. doi: 10.1542/peds.2018-3475.

  PMID: 30584062 BACKGROUND

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yi Ji, PhD MD

CONTACT

862885423453; jijiyuanyuan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 25, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)