Birthmark size may predict hidden defects in babies
NCT ID NCT07616323
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at babies with a common type of birthmark (infantile hemangioma) on the lower back, bottom, or genital area. The goal is to find the best size cutoff for the birthmark to decide which babies should be screened for LUMBAR syndrome, a condition that can involve hidden problems with the spine, kidneys, or other organs. Researchers will screen 70 infants with birthmarks at least 2 cm wide to see which ones have these hidden issues. The results will help doctors know when to recommend screening, avoiding unnecessary tests while catching serious problems early.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will consist of infants clinically diagnosed with infantile hemangioma involving the lower-body region, including the lumbosacral, sacrococcygeal, gluteal, perineal, perianal, external genital, or continuously extending lower-limb areas. Eligible patients will be prospectively and consecutively recruited from participating centers. The target population is selected because infantile hemangiomas in these anatomical regions, particularly large or segmental lesions, may be associated with LUMBAR syndrome or LUMBAR-associated structural anomalies. Patients with a maximal lesion diameter of ≥2.0 cm will be included in order to allow evaluation of different candidate screening thresholds. The 2.0-cm cutoff will serve as the enrollment threshold rather than the final screening threshold. This design enables comparison of clinically relevant candidate cutoffs, including ≥2.0 cm, ≥2.5 cm, ≥3.0 cm, ≥4.0 cm, and ≥5.0 cm, for predicting LUMBAR-associated anomalies.
- Ages
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0 to 10 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Clinically diagnosed infantile hemangioma. 2. Lesion located in at least one of the following regions: lumbosacral region, sacrococcygeal region, gluteal region, perineal region, perianal region, external genital region, or continuous extension to the lower limb. 3. Maximal lesion diameter ≥2.0 cm. 4. Written informed consent obtained from the parents or legal guardians. Exclusion Criteria: 1. Vascular anomaly other than infantile hemangioma, such as venous malformation, lymphatic malformation, arteriovenous malformation, or congenital hemangioma. 2. Previously diagnosed genetic or congenital syndrome unrelated to LUMBAR syndrome, which may independently explain the detected anomalies. 3. Incomplete clinical data preventing accurate measurement of lesion diameter. 4. Refusal of participation or refusal to complete core screening examinations. 5. Any condition judged by the investigators to be unsuitable for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China