The Neonatal Microbiome and NEC

The Neonatal Microbiome and Necrotizing enterocolitis (NEC) study is a multi-centered case control study testing the hypothesis that NEC is a direct or indirect consequence of the enteric biomass, its products, or both. Very low birth weight infants (VLBW; birth weight ≤ 1500 grams) admitted to the neonatal intensive care unit are prospectively followed over the first 5 week or until they reach 36 weeks gestation, whichever occurs later. VLBW infants with a lethal clinical condition are excluded. Over the course of the study period, prospective samples are obtained on all infants, and include all stools, and weekly blood samples, palm and oral swabs. Clinical data is collected over the course of the entire hospitalization. Cases are identified based on Bell's staging for NEC, requiring Bell's stage II (abdominal clinical signs and radiographic evidence of pneumatosis, portal venous gas or pneumoperitoneum). Controls are identified from the pool of prospectively enrolled subjects, matching for gestational age, birth weight, post-natal age and birth date. The microbial components of stool and its products before and at the onset of NEC, are then compared between cases and controls. The Aims of this proposal are to (1) conduct a case cohort study in which we compare clinical data and biological specimens from cases and well-matched controls; (2) determine if the kind and density of intestinal biomass, its gene content, and transcriptional activity are associated with, and potential determinants of, NEC; and (3) determine if host risk alleles for intestinal inflammation play a role in the development of NEC.]]>
INFORMED CONSENT TO PARTICIPATE IN A RESEARCH STUDYDatabase FormsManual of OperationsFor all participants: Inclusion criteria: birth weights are ≤ 1500 grams Exclusion criteria: severe medical problems evident at birth, such that survival is unlikely NEC cases are defined using Bell's staging for NEC criteria (Walsh, M.C. et al. Pediatr Clin North Am, 1986. 33(1): p. 179-201, PMID: 3081865). Only cases with Bell's Stage II or greater are included. These criteria include: Gastrointestinal Signs Radiographic Findings Stage I Abdominal distentionGastric residuals/emesisBloody stools Intestinal DilationIlius Stage II Plus abdominal tenderness+/- cellulitis Pneumotosis intestinalisPortal venous air Stage III Plus marked distention/tendernessPeritonitis Pneumoperitoneum Controls are matched for gestational age at birth and birth weight, date of birth, and postnatal age.]]>