Analysis of Integrated Clinical, Laboratory and Prognostic Data of Neonates With Necrotizing Enterocolitis

This is a retrospective study led by The Sixth Affiliated Hospital, Sun Yat-sen University, focusing on newborns diagnosed with necrotizing enterocolitis (NEC)-a serious gastrointestinal disease that threatens newborns' lives-between January 2023 and June 2025. Purpose of the study: NEC can lead to severe conditions like bowel perforation or even death, and it's hard for doctors to spot high-risk babies early with current tools. This study aims to analyze the babies' clinical information (e.g., birth weight, symptoms like belly swelling or bloody stools), blood test results (e.g., lactate levels, white blood cell counts), and organ function scores (nSOFA scores) to find indicators that can predict whether NEC will get worse or cause death. Questions the study tries to answer: Can combining metabolic indicators (like lactate), blood test parameters, and organ function scores better predict if a newborn with NEC will develop perforated NEC (a more severe form where the bowel has holes) or die during hospitalization? Are these combined indicators more reliable than single indicators alone? Study hypothesis: We guess that integrating metabolic markers (such as lactate), blood routine parameters, and nSOFA scores will be more accurate than using any single indicator to predict the progression of NEC and the risk of death in affected newborns.

NCT Number	NCT07207915
Lead Sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Conditions	Necrotizing Enterocolitis
Enrollment	400 participants
Start Date	2023-01-01
Primary Completion	2025-06-30 (estimated)
Study Completion	2025-09-18 (estimated)
Updated on ClinicalTrials.gov	2026-03-02