Pediatric Acute Severe Colitis Clinical Trial
Official title:
Managing Pediatric Acute Severe Colitis According to the 2011 ECCO-ESPGHAN Guidelines: Efficacy of Infliximab as a Rescue Therapy
Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening
event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a
second line therapy. This study was performed in consecutively observed pediatric patients
with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)-
European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN)
guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical
predictors of poor outcome.
Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative
Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment
through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein,
hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All
patients were treated according to the above mentioned guidelines for ASC and received
intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as
second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy
rate and the efficacy of IFX in avoiding colectomy were evaluated.
n/a
Observational Model: Cohort, Time Perspective: Prospective