Risk Factors for Poor Prognosis in Neonatal Necrotizing Enterocolitis (RFPNEC)

February 25, 2026 updated by: Wei Zhou, Guangzhou Women and Children's Medical Center

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Study Rationale Necrotizing Enterocolitis (NEC) is a life-threatening gastrointestinal disorder primarily affecting very low birth weight (VLBW) neonates (incidence: 5-12%). Around 20-40% of cases progress to severe disease requiring surgery, and survivors often face long-term complications (e.g., short-bowel syndrome, neurodevelopmental impairments). Despite advances in neonatal care, early identification of high-risk patients remains challenging due to nonspecific clinical/radiographic signs and insufficiently sensitive/specific conventional biomarkers.

    NEC pathophysiology involves intestinal ischemia-reperfusion injury, excessive immune activation, and microbial dysbiosis. Serum lactate (a marker of hypoperfusion/anaerobic metabolism) correlates with NEC severity but lacks specificity; peripheral blood cell (CBC) indices are accessible but understudied in combination with lactate. The Neonatal Sequential Organ Failure Assessment (nSOFA) score predicts overall NEC mortality but fails to stratify risk for perforated NEC (PNEC), a high-risk subtype. This study aims to address gaps by integrating metabolic (lactate), hematologic (CBC), and organ dysfunction (nSOFA) metrics for NEC prognosis.

  2. Study Design and Conduct This is a retrospective cohort study conducted at the Guangzhou Women and Children's Medical Center, approved by the institutional ethics committee and compliant with the Helsinki Declaration. The study period is January 2017 and December 2022; eligible participants are identified via retrospective review of electronic medical records (EMRs), with data extracted in a structured manner.

  3. Data Collection

    Structured EMR extraction captures key variables:

    Neonatal history: Sex, gestational age, birth weight, birth asphyxia (Apgar scores), small for gestational age (SGA) status, preterm complications (e.g., patent ductus arteriosus [PDA], respiratory distress syndrome [RDS]), feeding pattern, mechanical ventilation use.

    Maternal history: Delivery mode, chorioamnionitis, premature rupture of membranes.

    NEC-related parameters: Bell's staging, clinical manifestations (e.g., abdominal distension, pneumoperitoneum), complications (sepsis, shock), therapeutic interventions (surgery), in-hospital mortality.

    Laboratory/organ dysfunction indicators: Serum lactate (at NEC onset), CBC parameters (WBC, neutrophils, lymphocytes, platelets) and derived inflammatory indices, nSOFA score (at NEC onset).

  4. Statistical Analysis

    Analyses use SPSS 26.0 and GraphPad Prism 9.0:

    Data expression: Normally distributed variables (mean ± SD), skewed variables (median [IQR]), categorical variables (frequency %).

    Intergroup comparisons: Chi-square/Fisher's exact test (categorical), t-test/Mann-Whitney U test (continuous).

    Multivariate logistic regression: Includes variables with p<0.05 from univariate analysis to identify independent predictors.

    Mediation analysis (PROCESS macro 4.1, 1000 bootstraps): Decomposes total effects into direct/indirect paths.

    ROC curve analysis: Evaluates predictive performance of single/combined biomarkers (AUC as metric). All tests are two-tailed; p<0.05 is significant.

  5. Study Objectives Primary: Identify indicators predicting NEC progression and in-hospital mortality via analysis of clinical, metabolic, and laboratory data.

    Secondary: Explore integrated biomarkers for NEC severity stratification (e.g., Bell's staging, surgical need) to optimize clinical decision-making.

  6. Participant Protection All data are de-identified before analysis and stored in a password-protected database (accessible only to the study team). Informed consent is obtained from participants' legal representatives, who are informed of the right to withdraw at any time without penalty.

Study Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangdong, Guangdong, China, 510623
        • Guangzhou Women and Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

In this study, a retrospective analysis was conducted on 118 enrolled neonates with necrotizing enterocolitis (NEC), with data collected at Guangzhou Women and Children's Medical Center between January 2017 and December 2022.

Description

Inclusion Criteria:

(1) Diagnosis of NEC;

Exclusion Criteria:

  1. Congenital gastrointestinal malformations (e.g., intestinal atresia, Hirschsprung's disease) or spontaneous intestinal perforation;
  2. Hereditary metabolic disorders;
  3. refusal of participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mild NEC group
Bell's stage I and IIa
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.
Severe NEC group
Bell's stage IIb and III
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.
Surgical group
Patients with NEC who underwent surgical treatment
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.
Non-surgical group
Patients with NEC who did not undergo surgical treatment but opted for conservative treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of perforated necrotizing enterocolitis
Time Frame: Day 1 up to 3 months
Occurrence of perforated necrotizing enterocolitis
Day 1 up to 3 months
In-hospital mortality
Time Frame: Day 1 up to 3 months
In-hospital mortality
Day 1 up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bell's Staging System for Necrotizing Enterocolitis (NEC)
Time Frame: Day 1 up to 3 months
The Bell staging system is a standardized clinically validated classification tool for assessing the severity of necrotizing enterocolitis (NEC), integrating clinical manifestations, imaging, and laboratory data. Assessment criteria include: clinical symptoms (e.g., abdominal distension, bloody stools, feeding intolerance, shock); imaging findings (abdominal X-ray showing intestinal pneumatosis, portal venous gas, pneumoperitoneum, etc.); and laboratory results (thrombocytopenia, metabolic acidosis, etc.). Staging is determined by the research team through review of neonates' complete clinical, imaging, and laboratory records (extracted per the study's structured protocol) to ensure alignment with established Bell staging criteria.
Day 1 up to 3 months
Incidence of Surgical Necrotizing Enterocolitis (NEC)
Time Frame: Day 1 up to 3 months
"Surgical NEC" in this study refers to necrotizing enterocolitis (NEC) cases requiring surgical intervention. Its assessment relies on abdominal X-ray, abdominal ultrasound, and Bell's Staging System (as referenced in the Study Protocol with Statistical Analysis Plan.docx), with data extracted from neonates' electronic medical records per the protocol's data collection framework. Eligibility for classifying a case as surgical NEC is determined by: 1) Abdominal X-ray/ultrasound findings indicating severe NEC progression (e.g., pneumoperitoneum, unresponsive extensive pneumatosis intestinalis); 2) Bell's Staging (assessed per study criteria) confirming Stage III (Advanced NEC) - both consistent with clinical standards for initiating NEC-related surgery. The study team reviews these imaging results and staging data to confirm surgical NEC uniformly.
Day 1 up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Women and Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-NEC20240705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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