Guideline secondary analysis shows non-significant trend for higher enteral nutrition use in pediatric Crohn's disease registry groups

BackgroundExclusive enteral nutrition (EEN) is the first-line therapy for children with active luminal Crohn's disease (CD). However, its implementation in routine care is still limited. Given the impact of the disease on age-appropriate development and quality of life in children and adolescents, as well as the rising incidence rates, the use of this effective and low-risk therapy should be intensified. Previous studies have demonstrated that patient registries can provide support in following guideline-based care. This study represents a secondary analysis of the CLARA cluster-randomized trial and aims to describe real-world patterns of enteral nutrition (EN) use and implementation gaps for children with luminal CD.MethodsThis secondary analysis was based on data from a cluster-randomized, controlled trial (DRKS00015505). In the intervention group (IG), treatment providers documented the care of children and adolescents with inflammatory bowel disease (IBD) in the CEDATA-GPGE patient registry and received automated feedback on entered data and potential deviations from guideline recommendations (care deficits). In the control group (CG), treatments were documented as usual in patients' charts only. For this secondary analysis, initial treatment strategies for children with luminal CD during the first 90 days after diagnosis were compared between centers with registry-based documentation (IG) and those without (CG). The primary outcome was the documented use and pattern of EN, including the duration of EEN and combination therapies.ResultsOf the 319 children recruited (IG: 21 centers, n = 160 patients; CG: 26 centers, n = 159 patients), 170 patients were diagnosed with CD (IG: n = 88; CG: n = 82). A total of 110 patients were included in the analysis (IG: n = 58; CG: n = 52). A non-significant trend towards higher overall use of EN was observed in the IG (72.4% vs. 61.5%; p = 0.225). EEN for the recommended duration was uncommon in both groups (IG: 9.5%; CG: 18.8%). Patients who did not receive nutrition therapy as initial treatment (IG: n = 16; CG: n = 20) were predominantly treated with a combination of immunosuppressants, aminosalicylates (5-ASA), biologicals, and/or steroids (IG: n = 13; CG: n = 6). Overall, the use of steroids within the first 90 days after diagnosis was more frequent in the CG compared to the IG (CG: n = 22; IG: n = 16, p