Risk Stratification and Treatment Decisions in Infantile Hemangioma With Minimal or Arrested Growth (IH-MAGRST)

Infantile Hemangioma With Minimal or Arrested Growth Versus Typical Infantile Hemangioma: A Prospective Cohort Study of Risk Stratification and Treatment Decision-Making

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infantile Hemangioma (IH)
• Intervention / Treatment: Other: Routine Clinical Assessment and Risk Stratification

Detailed Description

Infantile hemangioma with minimal or arrested growth (IH-MAG) is a distinct clinical subtype of infantile hemangioma characterized by early-onset vascular lesions with minimal or absent proliferative growth. IH-MAG may be mistaken for capillary malformation or other vascular anomalies because of its relatively subtle growth pattern. However, some IH-MAG lesions, particularly segmental lesions or lesions in high-risk anatomic sites, may still be associated with ulceration, functional impairment, permanent disfigurement, or syndromic structural anomalies.

Standardized tools, including the 2019 American Academy of Pediatrics risk classification and the Hemangioma Severity Scale, are widely used to assess risk and severity in infantile hemangioma. Their clinical value has been studied in infantile hemangiomas overall, but their distribution and decision-making value in IH-MAG remain insufficiently defined.

This is a single-center, prospective, observational comparative cohort study. Infants aged 12 months or younger who present for their first systematic evaluation at a hemangioma specialty clinic will be enrolled if they are clinically diagnosed with IH-MAG or classic infantile hemangioma and meet the eligibility criteria. Participants will be assigned to two observational cohorts: an IH-MAG cohort and a classic infantile hemangioma cohort. No treatment will be assigned by the study protocol.

At baseline, demographic information, lesion characteristics, standardized clinical photographs, AAP risk category, Hemangioma Severity Scale score, and the clinician's initial management recommendation will be recorded. The primary outcome is the initial management recommendation after the first specialist assessment, categorized as active management or treatment versus observation. Active management may include topical therapy, systemic therapy, laser therapy, surgery, local treatment, imaging evaluation, specialist referral, or multidisciplinary assessment when clinically indicated. Observation refers to regular follow-up, parental education, photographic monitoring, and risk counseling without active treatment or additional active management at baseline.

Secondary outcomes include the distribution of AAP risk categories, Hemangioma Severity Scale scores, treatment intensity, reasons for treatment recommendation, use of imaging or specialist screening, changes in the management plan during follow-up, and diagnostic reclassification of suspected IH-MAG. Follow-up information will be collected at approximately 1, 3, and 6 months after baseline to document management implementation, lesion changes, complications, treatment adjustment, and diagnostic stability.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Yi Ji, PhD MD; Phone Number: 862885423453; Email: jijiyuanyuan@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

Age 12 months or younger at enrollment. First presentation to the hemangioma specialty clinic for systematic evaluation.

Clinical diagnosis of infantile hemangioma with minimal or arrested growth or typical infantile hemangioma.

No prior oral beta-blocker therapy, laser therapy, surgery, or other treatment that may substantially affect the baseline lesion status or initial management recommendation.

Availability of standardized clinical photographs and complete lesion documentation for risk assessment.

Written informed consent provided by a parent or legal guardian. Parent or legal guardian willing to participate in scheduled follow-up.

Exclusion Criteria:

• Congenital hemangioma, capillary malformation, venous malformation, arteriovenous malformation, or another non-infantile hemangioma vascular anomaly.

Prior systemic therapy, laser therapy, surgery, or other treatment before baseline evaluation that substantially alters lesion status or would affect the initial management recommendation.

Missing key data required for the primary outcome or risk assessment, including lesion location, lesion size, standardized clinical photographs, or the initial management recommendation.

Severe comorbid condition that makes the initial management recommendation primarily determined by non-hemangioma-related factors.

Parent or legal guardian unwilling or unable to provide informed consent or comply with follow-up.

For the confirmed IH-MAG analysis, suspected IH-MAG later reclassified because proliferative components involve 25% or more of the total lesion area.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Recommended for Active Management at the Initial Specialist Evaluation	The proportion of participants for whom active management is recommended after the initial specialist evaluation. 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.	At the initial specialist evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of AAP Risk Categories at Baseline	The distribution of risk categories according to the 2019 American Academy of Pediatrics clinical practice guideline. Participants will be classified as highest, high, intermediate, or low risk based on lesion size, anatomic location, morphology, number of lesions, and risk of complications.	At baseline
Hemangioma Severity Scale Total Score at Baseline	The Hemangioma Severity Scale total score at baseline. The score includes objective and subjective components, including lesion size, anatomic location, risk of associated structural anomalies, complications, pain, and risk of disfigurement.	At baseline
Distribution of Baseline Hemangioma Severity Scale Categories	At baseline	The distribution of participants across prespecified Hemangioma Severity Scale categories: 5 or lower, 6 to 10, and 11 or higher.

Collaborators and Investigators

• Sponsor: West China Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: infantile hemangioma; Infantile Hemangioma With Minimal or Arrested Growth
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Hemangioma; Hemangioma, Capillary
• Other Study ID Numbers: RCT20260621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No