Prospective Non-Randomized Diagnostic Pilot Study Using Fecal Calprotectin for Diagnosing Necrotizing Enterocolitis (NEC) in Very Low Birth Weight Infants

Abstract:

Aims: NEC represents significant morbidity and mortality in pre-mature infants. The lack of sensitive and specific diagnostic tools for early NEC diagnosis leads to invasive and expensive investigation and treatment.Following precaution rules, suspected cases are intensively treated with wide broad spectrum antibiotics however more than 90% of them would not have developed NEC. The aim of our study was to assess whether Fecal Calprotectin, a marker of mucosal inflammation, is an early predictor for incidence of NEC in very low birth weight infants.
Methods: Stool samples were collected daily from 55 very low birth weight infants (<1500g) from their 3rd to 60th day of life or until discharged from the hospital. Stool samples were stored at -20 C. Calprotectin levels were measured in stool using a standardized ELISA assay (PhiCal). White blood cell count, neutrophil count, bilious aspirates, feed residuals, abdominal distension were clinical observations monitored daily.

Results: On average, Calprotectin levels were higher in NEC (475μg/g stool) than in healthy subjects (190 μg/g). In addition, subjects with sepsis have also shown high Calprotectin levels (320 μg/g). In healthy infants, high Calprotectin levels at birth decrease markedly in ther first week however subjects with sepsis and NEC had shown an irregular pattern of Calprotectin spikes. Conclusions: Calprotectin levels were higher in NEC subjects; however it was not correlated with the clinical data. Further tests are necessary to investigate whether Calprotectin levels, clinical assessments and WBC taken together may be used as a diagnostic tool to differentiate NEC from other pathologic GI disorders. Therefore, preliminary data  indicates that increase of Calprotectin level may be correlated with bacterial gut colonization events.