Clinical trial · Observational
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
NCT07616323CI-TRIAL-00113058not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| LUMBAR Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- LUMBAR Syndrome
- interventionNames
- Diagnostic Test: MRI
Primary outcomes (1)
- measure
- The primary outcome will be the presence of at least one LUMBAR-associated structural anomaly detected by standardized screening.
- timeFrame
- 2 weeks
- description
- LUMBAR-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 outcomes (3)
- measure
- 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.
- timeFrame
- 2 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 10 Years
Show eligibility criteria text
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.
References
Publications (7)
- RESULTMetry D, Fernandez-Faith E, Haggstrom A, Keppler-Noreuil K, Frieden IJ. Segmental Infantile Hemangiomas That Involve the Midline Define Risk for LUMBAR Syndrome. Pediatr Dermatol. 2026 Jul-Aug;43(4):895-897. doi: 10.1111/pde.70178. Epub 2026 Apr 23. PMID 42021702
- RESULTBhatta D, Dev A, Chatterjee D, De D. Extensive Lower Body Infantile Hemangioma With Ulcerations, Spinal and Genitourinary Anomalies: A Case of LUMBAR Syndrome. Int J Dermatol. 2026 Jun;65(6):1300-1302. doi: 10.1111/ijd.70198. Epub 2025 Dec 9. No abstract available. PMID 41366822
- RESULTMartin B, Bui JK, Corpin A, Siegel DH, Metry DW. LUMBAR Syndrome State-Of-The-Art Review: Insights Into a Rare and Complex Condition. Pediatr Dermatol. 2025 Nov-Dec;42(6):1117-1125. doi: 10.1111/pde.70024. Epub 2025 Sep 18. PMID 40963452
- RESULTKrowchuk DP, Frieden IJ, Mancini AJ, Darrow DH, Blei F, Greene AK, Annam A, Baker CN, Frommelt PC, Hodak A, Pate BM, Pelletier JL, Sandrock D, Weinberg ST, Whelan MA; SUBCOMMITTEE ON THE MANAGEMENT OF INFANTILE HEMANGIOMAS. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. 2019 Jan;143(1):e20183475. doi: 10.1542/peds.2018-3475. PMID 30584062
- RESULTDrolet BA, Chamlin SL, Garzon MC, Adams D, Baselga E, Haggstrom AN, Holland KE, Horii KA, Juern A, Lucky AW, Mancini AJ, McCuaig C, Metry DW, Morel KD, Newell BD, Nopper AJ, Powell J, Frieden IJ. Prospective study of spinal anomalies in children with infantile hemangiomas of the lumbosacral skin. J Pediatr. 2010 Nov;157(5):789-94. doi: 10.1016/j.jpeds.2010.07.054. Epub 2010 Sep 9. PMID 20828712
- RESULTMetry D, Copp HL, Rialon KL, Iacobas I, Baselga E, Dobyns WB, Drolet B, Frieden IJ, Garzon M, Haggstrom A, Hanson D, Hollenbach L, Keppler-Noreuil KM, Maheshwari M, Siegel DH, Waseem S, Dias M. Delphi Consensus on Diagnostic Criteria for LUMBAR Syndrome. J Pediatr. 2024 Sep;272:114101. doi: 10.1016/j.jpeds.2024.114101. Epub 2024 May 15.