Clinical Characteristics of Infantile Hemangioma

Sponsor

West China Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03331744

Collaborator

(none)

1,000

Enrollment

Location

61.8

Anticipated Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Clinical Characteristics of Infantile Hemangioma: a Prospective Study

Actual Study Start Date :

Oct 6, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. [2 years]
Demographic characteristics in patients with IH.
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. [2 years]
Demographic characteristics in patients with infantile hepatic hemangioma.
Size, type of lesion (focal, multiple and diffuse), complication and outcome of infantile hepatic hemangioma. [2 years]
Clinical characteristics of infantile hepatic hemangioma
Location, size, complication and outcome in patients with ulcerated IHs. [2 years]
Clinical characteristics of ulcerated IHs. Phase of growth include proliferation, plateau and involution, and morphologic subtypes include localized, segmental, indeterminate and multifocal type.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Years

Sexes Eligible for Study:

All

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