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PI Name Protocol Number Protocol Title
BRANDT, MARY L. H-14757 NEONATAL SURGICAL DATABASE: NEC FORM PILOT

 

Background Info

Necrotizing Enterocolitis is a severe inflammatory disease of the intestine that occurs in premature and low birth weight infants. The clinical presentation of NEC can range from feeding intolerance to severe sepsis with cardiovascular collapse, but it is clear that the incidence of NEC correlates strongly with the degree of prematurity. After diagnosis of NEC, standard of practice is to institute bowel rest, gastric decompression, and broad-spectrum antibiotics. Many patients respond well to this treatment, while others deteriorate and develop intestinal necrosis or perforation. There is little available evidence to suggest what factors may help predict which infants are most likely to deteriorate. To date, no large prospective studies have followed infants diagnosed with NEC and determined their course. Identification of risk factors for deterioration could allow more intensive therapy to be focused on those most likely to benefit.

Hypothesis

The purpose of the database is to identify general outcome trends based on accepted standards of care and to identify risk factors for progression of NEC.

Design

Multi-center, observational, prospective cohort database

Sample size

150

Entry criteria

Patients must meet at least one criterion from each of the following three categories: Historical Factors – *Feeding intolerance defined as vomiting of 2 or more feedings within 24 hours or any vomitus containing bile, or the presence of gastric residuals of volume greater than 6 cc/kg or any aspirate containing bile *Apneic/bradycardic episodes *Oxygen desaturation episode not otherwise explained *Guaiac positive or grossly bloody stoolsPhysical Examination Findings - *Abdominal distention recorded by practitioner *Capillary refill time greater than 2 seconds *Abdominal wall discoloration *Abdominal tenderness Radiographic Findings - *Pneumatosis intestinalis *Portal venous gas *Ileus *Dilated bowel *Pneumoperitoneum *Air/fluid levels *Thickened bowel walls *Ascites or peritoneal fluid *Free intraperitoneal air

Results/conclusions to date

148 patients enrolled and 25 deaths

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