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Background: Spinal cord tumors (SCTs) comprise 10% of all central nervous system (CNS) tumors. Pediatric SCTs are often excluded and underrepresented in clinical trials though exclusion rates haven't been reported. Methods: We reviewed all interventional clinical trials recruiting patients <21 years with SCTs on ClinicalTrials.gov between 1989 and 2023. Results: Five hundred and two CNS tumor trials were identified, of which 255 included SCTs and/or spincal metastases. Among these, 96.5% were open to all CNS tumors (brain or spine); however, only 3.5% were exclusive to spine tumors. One trial was specific to pediatric spine tumors (inclusive of bone, soft tissue, and neural tumors); no trial was specific to primary pediatric SCTs. Most trials were located in North America, with multisite investigations being more common than single-institution designs. Trials frequently evaluated interventions/treatments (89%), supportive care/quality of life measures (7.1%), or diagnostic protocols (3.1%). Among included treatment paradigms, systemic therapies using cytotoxic chemotherapies, targeted therapies, and/or immunotherapies were more common among brain/spine trials, while radiotherapy, surgical adjuncts, and/or local drug delivery more frequently occurred in spinal tumor trials. Conclusions: Though SCTs comprise 10% of pediatric CNS tumors, they remain underrepresented in clinical trials. This lack of trials specific to advancing pediatric SCTs management highlights an area of clinical and research need.
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OBJECTIVE: Intrathecal baclofen (ITB) pumps are commonly used in pediatric patients with cerebral palsy (CP) and medically refractory spasticity. However, catheter malfunction and associated risk factors are not well understood. The aim of this study was to examine potential risk factors for spinal catheter malfunction and characterize postoperative follow-up to understand the clinical consequences. METHODS: Patients who received ITB pump replacement or revision at Boston Children's Hospital between 2010 and 2023 were retrospectively reviewed. The spinal catheter revision cohort (SCRC) included patients whose spinal catheter was occluded requiring lumbar catheter revision. The second cohort included abdominal pump replacements only (APRC). Between-group comparisons and multivariable regression identified factors associated with catheter revision and postoperative outcomes. RESULTS: Forty-one (33.6%) patients underwent spinal catheter revision and were compared with 81 patients (66.4%) who underwent abdominal pump replacement only. Younger age at surgery and an elevated preoperative lower-extremity modified Ashworth scale grade were associated with spinal catheter revision (p < 0.05). Catheter model type, tip location, and history of spinal fusion were not associated with obstruction. Postoperatively, SCRC patients experienced a higher rate of infection (17.1%) relative to APRC patients (0%) within 30 days from their ITB pump replacement procedure (p < 0.05) and greater likelihood of subsequent ITB system removal compared with the APRC (24.4% vs 7.4%, p < 0.05). Although not differing preoperatively, SCRC patients had lower postoperative ITB doses when compared with the APRC group (median dose 143 vs 350 µg/day, p < 0.05) at hospital discharge and remained statistically different at the 6-month and 1-year follow-ups (p < 0.05). There were no postoperative differences in baclofen overdose, withdrawal, or median number of hospital readmissions within 30 days. Overall, 31.7% of spinal catheter revisions were unanticipated by the clinical team at time of surgery. CONCLUSIONS: Younger age at surgery and increased preoperative lower-extremity tone may be risk factors for catheter obstruction, resulting in a higher rate of postoperative infection and subsequent ITB pump removal compared with pump replacement alone. Spinal catheter occlusion can complicate revision or replacement procedures, especially when unanticipated. Routine clinical assessment may be inadequate for diagnosing insidious catheter malfunction. Catheter occlusion deserves further study, and routine assessment of catheter patency may be warranted to prevent suboptimal tone therapy.