{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T06:47:41Z","timestamp":1793256461082,"version":"4.5.0"},"reference-count":42,"publisher":"Georg Thieme Verlag KG","issue":"02","license":[{"start":{"date-parts":[[2024,7,10]],"date-time":"2024-07-10T00:00:00Z","timestamp":1720569600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Infant Bacterial Therapeutics"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Am J Perinatol"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:p>\n            Objective\u2003Necrotizing enterocolitis (NEC) classically is diagnosed by radiographic demonstration of pneumatosis intestinalis\/portal venous gas (PI\/PVG). This study examines clinical characteristics of NEC confirmed by independent evaluation of abdominal radiographs, taken for clinical signs of NEC, or by pathologic findings at laparotomy or autopsy (confirmed NEC [cNEC]).<\/jats:p><jats:p>\n            Study Design\u2003The investigated cohort included 1,382 extremely low birth weight (BW) infants (BW range: 500\u20131,000\u2009g) with median 27 weeks (range: 23\u201332) gestational age (GA) at birth. They were randomized into the placebo-controlled \u201cConnection Trial\u201d of the new biological drug candidate IBP-9414 with cNEC as one primary endpoint.<\/jats:p><jats:p>\n            Results\u2003Total 119 infants (8.6%) had cNEC diagnosed at median 14 days of age by confirming PI\/PVG at X-ray adjudication (n\u2009=\u2009111) and\/or by surgery\/autopsy (n\u2009=\u200921). Sixteen percent of cNEC cases died. Adverse events of NEC were reported in 8.5% of infants and 4.1% had NEC diagnosed by radiology and surgery\/autopsy at the participating centers. Regression analyses showed that the risk of cNEC decreased by 11 to 30% for every 100-g increment in BW and single-week increment in GA and associated cNEC with odds ratios (ORs)\u2009&gt;\u20092.0 for gastrointestinal (GI) perforation and obstruction, hypotension, hypokalemia, hypophosphatemia, and death. Comparing risks of cNEC in infants below and above 750-g BW showed higher ORs (2.7\u20134.3) for GI perforation, hypotension, hypokalemia, and renal complications in the smaller infants, whereas the bigger infants had higher ORs (1.9\u20133.2) for serious non-GI events, late-onset sepsis (LOS), and death. Predictors of cNEC (hazard ratio, HR\u2009&gt;\u20091.5) included serious non-GI events (mainly infections), hyponatremia, and hyperglycemia, whereas the HR was 0.52 for intravenous antibiotics. After cNEC diagnosis, there were higher rates of GI perforation and obstruction, hypotension, hypokalemia, and LOS.<\/jats:p><jats:p>\n            Conclusion\u2003Independent adjudication of abdominal radiographs increased radiological recognition of NEC and proved to be feasible in a multicenter study setting as well as able to diagnose clinically relevant NEC.<\/jats:p><jats:p>\n            Key Points\n          <\/jats:p>","DOI":"10.1055\/s-0044-1788275","type":"journal-article","created":{"date-parts":[[2024,7,10]],"date-time":"2024-07-10T22:55:26Z","timestamp":1720652126000},"page":"268-280","source":"Crossref","is-referenced-by-count":10,"title":["Clinical Characteristics of Necrotizing Enterocolitis Diagnosed by Independent Adjudication of Abdominal Radiographs, Laparotomy, or Autopsy in Preterm Infants in the \u201cConnection Trial\u201d"],"prefix":"10.1055","volume":"42","author":[{"given":"Josef","family":"Neu","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, UF Health Shands Children's Hospital, Gainesville, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachana","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Tuft's Children's Hospital, Tuft's University School of Medicine, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihaela","family":"Demetrian","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Spitalul Clinic Filantropia, Bucharest, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaime","family":"Flores-Torres","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Morsani College of Medicine, University of South Florida, Tampa, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Hudak","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Florida College of Medicine, Jacksonville, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John A.","family":"Zupancic","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anders","family":"Kronstr\u00f6m","sequence":"additional","affiliation":[{"name":"Infant Bacterial Therapeutics, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonas","family":"Rastad","sequence":"additional","affiliation":[{"name":"Infant Bacterial Therapeutics, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Staffan","family":"Str\u00f6mberg","sequence":"additional","affiliation":[{"name":"Infant Bacterial Therapeutics, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus","family":"Thuresson","sequence":"additional","affiliation":[{"name":"Infant Bacterial Therapeutics, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"The \u201cConnection Study\u201d Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2024,7,10]]},"reference":[{"issue":"06","key":"ref1","doi-asserted-by":"crossref","first-page":"370","DOI":"10.1016\/j.siny.2018.07.004","article-title":"Necrotizing enterocolitis comes in different forms: historical perspectives and defining the disease","volume":"23","author":"J Neu","year":"2018","journal-title":"Semin Fetal Neonatal Med"},{"issue":"01","key":"ref2","doi-asserted-by":"crossref","first-page":"344","DOI":"10.1186\/s12887-020-02231-5","article-title":"Global incidence of necrotizing enterocolitis: a systematic review and meta-analysis","volume":"20","author":"A Alsaied","year":"2020","journal-title":"BMC 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