CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400 enrolled
Drug / intervention
Observational retrospective cohort studyother
Likely dose
Not stated in record
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Search/NCT07207915
NCT07207915N/ACompleted

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

Sixth Affiliated Hospital, Sun Yat-sen University·observational·Posted Oct 6, 2025·Updated Mar 2, 2026

In Brief

An observational study evaluating Observational retrospective cohort study for Necrotizing Enterocolitis. Completed, enrolled 400 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedOct 6, 2025
Enrollment StartJan 1, 2023
Primary CompletionJun 30, 2025
Study CompletionSep 18, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9 months ago

Interventions

Observational retrospective cohort studyother

Observational retrospective cohort study, data collection was performed via structured extraction from electronic medical records: Includingclinical characteristics, metabolic indicators, laboratory parameters, prognosis, and outcomes.