Actively Recruiting
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2024-07-16
4680
Participants Needed
4
Research Sites
21 weeks
Total Duration
A
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
Lennox-Gastaut syndrome (LGS) is a rare and serious form of epilepsy that begins in infancy and early childhood. It causes seizures that often require emergency medical care and hospital stays, disrupting life for both the child and their family. LGS is also linked to difficulties in motor skills, communication, eating, and daily functioning. This research aims to compare two common treatments—adding more anti-seizure medications versus palliative surgery—to see which better reduces emergency visits and hospitalizations, as well as lessens developmental and functional challenges in children with LGS. The study is observational and includes two parts. The first part involves looking back at medical records from seven pediatric hospitals to compare outcomes for children treated with either additional medications approved for LGS or palliative surgeries like neurostimulation. The second part describes how these treatments are used across 18 hospitals, analyzing differences over time and by patient characteristics such as age, medical conditions, race, ethnicity, and insurance type. Participants' medical records will be reviewed to assess seizure-related emergency healthcare use over two years and parent-reported clinical outcomes related to function. The study also seeks to improve research methods and infrastructure for studying LGS and other rare epilepsies. The results aim to help parents and doctors make better-informed treatment decisions for children affected by this lifelong condition.
CONDITIONS
Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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Duration - 2 years
Participants who undergo routine care are observed for seizure-related emergency health care utilization and functional outcomes over time.
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Total: 4 locations
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
2
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Nationwide Children's
Columbus, Ohio, United States, 43205
Actively Recruiting
S
Sandi Lam, MD MBA
M
Marc Rosenman, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Sandi Lam, Marc Rosenman, Tracy Dixon-Salazar...
https://pubmed.ncbi.nlm.nih.gov/40606139