104. A Bedside Point-of-care Novel Biomarker to Diffentiate Necrotizing Enterocolitis from Isolated Intestinal Perforation in Neonatal ICU
Session: Oral Abstract Session: Diagnostics: Typing/Sequencing
Thursday, October 8, 2015: 11:45 AM
Room: 7--AB
Background: Inter-alpha inhibitors (IAI) are natural serine protease inhibitors that play a crucial role in modulating host response to inflammatory insults. Blood levels of IAI are significantly reduced in neonatal sepsis and necrotizing enterocolitis (NEC). Currently, there is no biomarker is available to differentiate NEC from isolated intestinal perforation (IP), serious morbidities affecting premature infants. Primary objective of this study is to compare blood levels of IAI in infants with NEC, IP and matched controls and contrast them to C-reactive protein (CRP).

Methods: Prospective observational unmasked study. Blood samples were collected at onset of symptoms from infants diagnosed with NEC, IP and matched controls admitted to NICU of Women and Infants Hospital of RI. Infants with NEC were diagnosed by Bell's staging criteria (all had ≥ stage 2 or 3). Infants with IP were diagnosed by clinical and radiological findings. Infants in the control group had non-specific abdominal disorders but no radiographic evidence of NEC or IP and no disease progression. Controls were matched for gestational age, gender and weight. Plasma IAI and CRP levels were quantified using competitive enzyme-linked immunosorbent assay with intra-assay variability (coefficient of variation) of <3% . Mean biomarker levels were subjected to analysis of variance and post-hoc analysis.

Results: There were 28 infants studied in three groups.
Varibale NEC (n=5) IP (n=6) Controls (n=17) P-value
Gestational age, weeks* 275±34 264±15 275±26 0.64
Age at presentation, days* 12.2±11.5 8.1±4.8 10.2±7.1 0.11
Birth weight, grams* 1025±705 825±243 1067±570 0.69
Gender, male % 20% 66% 35% 0.25
IAI at onset, µg/ml* 139 ± 21 319 ± 72 276 ± 110 0.01
CRP at  onset, ng/ml* 18.4 ± 24.9 15.8 ± 9.6 6.9 ± 14.2 0.27

Plasma IAI levels were significantly lower in infants with NEC at onset when compared to those with IP and matched controls (p<0.004 and p<0.01 respectively). In contrast, plasma CRP levels were not different among infants with NEC, IP and matched controls at disease onset (P 0.27).

Conclusion: As a biomaker, IAI may assist in early detection of NEC from controls and differentiate NEC from IP at disease onset. IAI has higher discrimination than that of CRP. This differentiation at disease onset may lead to earlier effective treatments, antimicrobial stewardship and improved outcomes.

Birju Shah, MD, MPH, Yow-Pin Lim, PhD and James Padbury, MD, Pediatrics, Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI


B. Shah, None

Y. P. Lim, ProThera Biologics: Chief Scientific Officer , Research grant

J. Padbury, None

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