HemangiomaNCT03331744
Clinical Characteristics of Infantile Hemangioma
An observational study of Hemangioma, run by West China Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Hemangioma
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 6 Oct 2017to 1 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Child
Study population: Patients with the diagnosis of IHs will be recruited from the Department of Pediatric Surgery, West China Hospital of Sichuan University.
Who may be able to join
- Age ≤6 years old
- Diagnose of IHs
- Consent of both parents (or the person having parental authority in families)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Yi Ji, MD, PhD, +86 28 85423453, jijiyuanyuan@163.com
Siyuan Chen, +86 28 85423460, siy_chen@163.com
About this study
Official title: 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.
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.
- Conditions
- Hemangioma
- Keywords
- Infantile hemangioma, Infantile hepatic hemangioma, Ulcerated infantile hemangioma, Clinical characteristics, Demographic characteristics
- Medical subject headings
- Hemangioma, Hemangioma, Capillary
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: 2 years
Size, type of lesion (focal, multiple and diffuse), complication and outcome of infantile hepatic hemangioma.
Clinical characteristics of infantile hepatic hemangioma
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start6 Oct 2017
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Ji, West China Hospital
- Investigators
- Yi Ji, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331744
- Sponsor's protocol ID
- 2017-118
- Status last verified
- Jan 2024
- First submitted
- 12 Oct 2017
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lan YR, Zhang ZX, Yang LY, Yang M, Qiu T, Zhang KZ, Zhou JY, Gong X, Zhang XP, He CS, Peng Q, Hou F, Shan W, Bao PQ, Xia CC, Chen SY, Ji Y. Propranolol monotherapy versus propranolol plus prednisone for diffuse infantile hepatic haemangioma: a randomized clinical trial. World J Pediatr. 2026 Jun;22(6):655-663. doi: 10.1007/s12519-026-01070-1. Epub 2026 Jul 14.
PubMed 42449025Zhang K, Qiu T, Zhou J, Gong X, Lan Y, Zhang Z, Ji Y. Comparison of Infantile Hemangiomas in Male and Female Infants: A Prospective Study. J Dermatol. 2025 Oct;52(10):1555-1560. doi: 10.1111/1346-8138.17885. Epub 2025 Jul 25.
PubMed 40715016Zhou J, Zhang Z, Lan Y, Yang M, Qiu T, Yang K, Zhang X, Jiang X, Hou F, Shan W, Kong F, Hu F, Chen S, Ji Y. Long-Term Outcomes of Oral Propranolol for Facial Infantile Hemangioma. Plast Reconstr Surg. 2026 Jan 1;157(1):142-149. doi: 10.1097/PRS.0000000000012186. Epub 2025 May 6.
PubMed 40327835Gong X, Yang M, Zhang Z, Qiu T, Zhou J, Shan W, Zhang X, Lan Y, Bao P, Zhou Z, Yang C, Zhang Y, Li T, Guo J, Guo J, Lu G, Kong F, Zhang Y, Chen S, Ji Y. Clinical characteristics and managements of congenital hepatic hemangioma: a cohort study of 211 cases. Hepatol Int. 2025 Jun;19(3):682-691. doi: 10.1007/s12072-024-10756-5. Epub 2024 Nov 29.
PubMed 39612031Gong 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Infantile Hemangioma: a Prospective Study
- ClinicalTrials.gov ID
- NCT03331744
- Acronym / sponsor ID
- 2017-118
- Conditions
- Hemangioma
- Keywords
- Infantile hemangioma, Infantile hepatic hemangioma, Ulcerated infantile hemangioma, Clinical characteristics, Demographic characteristics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients with the diagnosis of IHs will be recruited from the Department of Pediatric Surgery, West China Hospital of Sichuan University.
Key inclusion criteria (3 listed)
- Age ≤6 years old
- Diagnose of IHs
- Consent of both parents (or the person having parental authority in families)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Location, size, phase of growth, morphologic subtypes, complication and outcome of IHs in patients.
Time frame: 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.
4 secondary outcomes
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.
Time frame: 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.
Time frame: 2 years
Size, type of lesion (focal, multiple and diffuse), complication and outcome of infantile hepatic hemangioma.
Time frame: 2 years
Location, size, complication and outcome in patients with ulcerated IHs.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Derived from this study: PubMed 42449025Lan YR, Zhang ZX, Yang LY, Yang M, Qiu T, Zhang KZ, Zhou JY, Gong X, Zhang XP, He CS, Peng Q, Hou F, Shan W, Bao PQ, Xia CC, Chen SY, Ji Y. Propranolol monotherapy versus propranolol plus prednisone for diffuse infantile hepatic haemangioma: a randomized clinical trial. World J Pediatr. 2026 Jun;22(6):655-663. doi: 10.1007/s12519-026-01070-1. Epub 2026 Jul 14.
- Derived from this study: PubMed 40715016Zhang K, Qiu T, Zhou J, Gong X, Lan Y, Zhang Z, Ji Y. Comparison of Infantile Hemangiomas in Male and Female Infants: A Prospective Study. J Dermatol. 2025 Oct;52(10):1555-1560. doi: 10.1111/1346-8138.17885. Epub 2025 Jul 25.
- Derived from this study: PubMed 40327835Zhou J, Zhang Z, Lan Y, Yang M, Qiu T, Yang K, Zhang X, Jiang X, Hou F, Shan W, Kong F, Hu F, Chen S, Ji Y. Long-Term Outcomes of Oral Propranolol for Facial Infantile Hemangioma. Plast Reconstr Surg. 2026 Jan 1;157(1):142-149. doi: 10.1097/PRS.0000000000012186. Epub 2025 May 6.
- Derived from this study: PubMed 39612031Gong X, Yang M, Zhang Z, Qiu T, Zhou J, Shan W, Zhang X, Lan Y, Bao P, Zhou Z, Yang C, Zhang Y, Li T, Guo J, Guo J, Lu G, Kong F, Zhang Y, Chen S, Ji Y. Clinical characteristics and managements of congenital hepatic hemangioma: a cohort study of 211 cases. Hepatol Int. 2025 Jun;19(3):682-691. doi: 10.1007/s12072-024-10756-5. Epub 2024 Nov 29.
- Derived from this study: PubMed 35751738Gong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Ji principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemangioma, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Ji (+86 02885423453, jijiyuanyuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Location, size, phase of growth, morphologic subtypes, complication and outcome of IHs in patients. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331744, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.