CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 118 enrolled
Drug / intervention
Observational retrospective cohort studyother
Likely dose
Not stated in record
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Search/NCT07249697
NCT07249697N/ACompleted

Risk Factors for Poor Prognosis in Neonatal Necrotizing Enterocolitis

Guangzhou Women and Children's Medical Center·observational·Posted Nov 25, 2025·Updated Feb 27, 2026

In Brief

An observational study evaluating Observational retrospective cohort study for Necrotizing Enterocolitis. Completed, enrolled 118 participants across 1 site.

Detailed Summary

This is a retrospective study led by Guangzhou Women and Children's Medical Center, focusing on newborns diagnosed with necrotizing enterocolitis (NEC)-a serious gastrointestinal disease that threatens newborns' lives-between January 2017 and December 2022. 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
201820192020202120222023202420252026
First PostedNov 25, 2025
Enrollment StartJul 1, 2017
Primary CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 7 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.