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

NCT07207915 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

  • Necrotizing Enterocolitis

Interventions

OTHER

Observational retrospective cohort study

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

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Hu Hao, Doctor · Sixth Affiliated Hospital, Sun Yat-sen University

Eligibility

Min Age
1 Day
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-06-30
Completion
2025-09-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07207915 on ClinicalTrials.gov