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Screening LUMBAR Syndrome in Infants With Infantile Hemangiomas

Diameter Threshold for Screening LUMBAR Syndrome in Infants With Lumbosacral, Sacrococcygeal, Perineal, and Gluteal Infantile Hemangiomas: A Prospective Multicenter Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07616323
Enrollment
70
Registered
2026-06-01
Start date
2026-06-01
Completion date
2027-06-30
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LUMBAR Syndrome

Keywords

LUMBAR syndrome, screening, infantile hemangioma

Brief summary

The objective of this study is to determine the maximal diameter threshold at which infants with lumbosacral, sacrococcygeal, perineal, gluteal, or lower-limb extending infantile hemangiomas should undergo screening for LUMBAR syndrome.

Detailed description

Infantile hemangiomas located in the lumbosacral, sacrococcygeal, perineal, gluteal, or lower-limb-extending regions may be associated with LUMBAR syndrome. LUMBAR syndrome refers to a spectrum of regional congenital anomalies associated with lower-body infantile hemangiomas, including lower-body hemangioma, urogenital anomalies, ulceration, myelopathy or spinal dysraphism, bony deformities, anorectal malformations, arterial anomalies, and renal anomalies. However, the optimal lesion size threshold for initiating systematic screening remains unclear. In current clinical practice, some patients with large or segmental hemangiomas undergo magnetic resonance imaging and systemic evaluation, whereas others with smaller but potentially high-risk lesions may not be screened. Therefore, a clinically practical and evidence-based diameter threshold is needed to guide LUMBAR syndrome screening. Previous prospective evidence has suggested that lumbosacral infantile hemangiomas larger than 2.5 cm may be associated with a high rate of spinal anomalies. However, whether this 2.5-cm threshold applies to hemangiomas involving the sacrococcygeal, perineal, gluteal, or lower-limb-extending regions remains uncertain. Therefore, this study aims to prospectively evaluate the relationship between maximal lesion diameter and LUMBAR-associated anomalies and to identify an optimal screening threshold.

Interventions

DIAGNOSTIC_TESTMRI

Screening for LUMBAR syndrome by MRI

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome will be the presence of at least one LUMBAR-associated structural anomaly detected by standardized screening.2 weeksLUMBAR-associated anomalies include spinal or spinal cord anomalies, urogenital anomalies, renal anomalies, anorectal malformations, bony deformities, arterial anomalies, or other regional developmental abnormalities consistent with the LUMBAR spectrum.

Secondary

MeasureTime frame
Detection rate of spinal or spinal cord anomalies.Detection rate of anorectal, perineal, or urogenital anomalies. Detection rate of arterial or lower-limb developmental anomalies.2 weeks
Detection rate of renal or urinary tract anomalies.Detection rate of LUMBAR-associated anomalies according to lesion location.Detection rate according to lesion diameter category.2 weeks
Proportion of patients requiring further specialist treatment or intervention.6 months

Countries

China

Contacts

CONTACTYi Ji MD, PhD
jijiyuanyuan@163.com86 28 85423453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026