ClinicalTrials.gg
RecruitingNCT03331744Updated Jan 24, 2024

Clinical Characteristics of Infantile Hemangioma

An observational study in Hemangioma, sponsored by West China Hospital. Recruiting at 1 site in China. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2024-01-24.

Primary conditionHemangioma, CapillaryRegistry: HemangiomaReclassifiedWhy we changed it
Registry
Hemangioma — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hemangioma, Capillary
Why
  1. The study's title name Hemangioma, Capillary, a narrower term within Hemangioma.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by West China Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Oct 2017; still recruiting 9 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
Up to 6 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Hemangioma

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Keywords

  • Infantile hemangioma
  • Infantile hepatic hemangioma
  • Ulcerated infantile hemangioma
  • Clinical characteristics
  • Demographic characteristics
03

In context

Hemangioma, Capillary Reclassified

33 studies on the registry are indexed under Hemangioma, Capillary; 5 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 187 across 12 observational studies indexed under Hemangioma, Capillary.

Browse Hemangioma, Capillary studies →

Lead sponsor

West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.

Compared within Hemangioma, Capillary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hemangioma. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Up to 6 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Congenital hemangioma, kaposiform hemangioendothelioma, or other vascular anomalies
  • Age>6 years
  • Hemangioma has been previous treated with , laser, cryotherapy, or only other treatments
  • Patients with an inability to participate or to follow the study treatment and assessment plan
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. 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.

    Time frame: 2 years

  3. Size, type of lesion (focal, multiple and diffuse), complication and outcome of infantile hepatic hemangioma.

    Clinical characteristics of infantile hepatic hemangioma

    Time frame: 2 years

  4. 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.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
    Recruiting
    • Yi Ji, MD, PhD · Contactjijiyuanyuan@163.com · +86 28 85423453
    • Siyuan Chen · Contactsiy_chen@163.com · +86 28 85423460
    • Yi Ji, MD, PhD · Principal investigator
    • Bo Xiang, MD, PhD · Sub investigator
    • Lin Zhong, MD · Sub investigator
    • Zhicheng Xu, MD · Sub investigator
    • Kaiying Yang, MD · Sub investigator
    • Suhua Peng, MD · Sub investigator
08

References and documents

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. PubMed 35751738 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03331744
Responsible party
Yi Ji (Principal Investigator, West China Hospital) — Principal investigator
First posted
Nov 6, 2017
Start date
Oct 6, 2017
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Jan 24, 2024

Study contacts

Yi Ji
Contact
jijiyuanyuan@163.com
+86 02885423453
Yi Ji
principal investigator · West China Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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