Clinical trial NCT03331744: Clinical Characteristics of Infantile Hemangioma
Official title: Clinical Characteristics of Infantile Hemangioma: a Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemangioma
Keywords: Infantile hemangioma
Infantile hepatic hemangioma
Ulcerated infantile hemangioma
Clinical characteristics
Demographic characteristics
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 1000
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Location, size, phase of growth, morphologic subtypes, complication and outcome of IHs in patients.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: Size, type of lesion (focal, multiple and diffuse), complication and outcome of infantile hepatic hemangioma.
timeFrame: 2 years
measure: Location, size, complication and outcome in patients with ulcerated IHs.
timeFrame: 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Yi Ji
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.