Clinical Characteristics of Infantile Hemangioma

Clinical Characteristics of Infantile Hemangioma: a Prospective Study

The primary purpose of this study is to identify the clinical characteristics of infantile hemangioma (IH) in our single center in China. The second objective of the study is to identify the clinical features of infantile hepatic hemangioma (IHH) and ulceration in patients with IHs.

Study Overview

• Status: Recruiting
• Conditions: Hemangioma

Detailed Description

Infantile hemangioma (IH) is the most common benign tumor of infancy with an estimated prevalence of 4%-5%. IHs may be presented in any part of body including the visceral organs, but are preferentially located on the face, head and neck area. IHs exhibit a characteristic life cycle consisting of a rapid proliferating phase within the first year of life followed by a slowly involuted phase lasting for up to five years. Although most resolve over time without major sequelae, a significant subset can result in severe complications including disfiguring and ulceration, some even could impair organ functions and threaten patients' life. Risk factors of IHs have been identified including multiple gestation, low birth weight, prematurity, white race, eclampsia and placental abnormalities. However, the exact occurrence, clinical features and risk factors of IHs is still unknown in Chinese patients because of the lack of large scale of prospective studies. In addition, characteristics of ulceration of IHs and infantile hepatic hemangiomas (IHHs) are also not well documented. Therefore, it's important to perform this prospective study to determine the clinical features of Chinese patients with IHs, and this study will also make contributions to the prevents, diagnoses and treatments of IHs.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Yi Ji; Phone Number: +86 02885423453; Email: jijiyuanyuan@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Yi Ji, MD, PhD; Phone Number: +86 28 85423453; Email: jijiyuanyuan@163.com
      • Principal Investigator: Yi Ji, MD, PhD
      • Sub-Investigator: Kaiying Yang, MD
      • Contact: Siyuan Chen; Phone Number: +86 28 85423460; Email: siy_chen@163.com
      • Sub-Investigator: Bo Xiang, MD, PhD
      • Sub-Investigator: Lin Zhong, MD
      • Sub-Investigator: Zhicheng Xu, MD
      • Sub-Investigator: Suhua Peng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with the diagnosis of IHs will be recruited from the Department of Pediatric Surgery, West China Hospital of Sichuan University.

Description

Inclusion Criteria:

• Age ≤6 years old
• Diagnose of IHs
• Consent of both parents (or the person having parental authority in families)

Exclusion Criteria:

• Congenital hemangioma, kaposiform hemangioendothelioma, or other vascular anomalies
• Age>6 years
• Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments
• Patients with an inability to participate or to follow the study treatment and assessment plan

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Location, size, phase of growth, morphologic subtypes, complication and outcome of IHs in patients.	Clinical characteristics of infantile hemangioma. Phase of growth include proliferation, plateau and involution phase. Morphologic subtypes include localized, segmental, indeterminate and multifocal type.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic information of IH about patient gender, birth weight, race, gestational age, prenatal testing procedures, placental abnormalities, maternal complications during pregnancy, type of fertilization and delivery type are collected.	Demographic characteristics in patients with IH.	2 years
Demographic information of IHH about patient gender, birth weight, race, gestational age, prenatal testing procedures, placental abnormalities, maternal complications during pregnancy, type of fertilization and delivery type are collected.	Demographic characteristics in patients with infantile hepatic hemangioma.	2 years
Size, type of lesion (focal, multiple and diffuse), complication and outcome of infantile hepatic hemangioma.	Clinical characteristics of infantile hepatic hemangioma	2 years
Location, size, complication and outcome in patients with ulcerated IHs.	Clinical characteristics of ulcerated IHs. Phase of growth include proliferation, plateau and involution, and morphologic subtypes include localized, segmental, indeterminate and multifocal type.	2 years

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Yi Ji, West China Hospital

Publications and helpful links

General Publications

• Gong X, Qiu T, Feng L, Yang K, Dai S, Zhou J, Zhang X, Chen S, Ji Y. Maternal and Perinatal Risk Factors for Infantile Hemangioma: A Matched Case-Control Study with a Large Sample Size. Dermatol Ther (Heidelb). 2022 Jul;12(7):1659-1670. doi: 10.1007/s13555-022-00756-4. Epub 2022 Jun 25.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Clinical characteristics; Infantile hemangioma; Infantile hepatic hemangioma; Ulcerated infantile hemangioma; Demographic characteristics
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Congenital Abnormalities; Skin Abnormalities; Neoplasms, Vascular Tissue; Hemangioma, Capillary; Port-Wine Stain; Hemangioma
• Other Study ID Numbers: 2017-118

Plan for Individual participant data (IPD)

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