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

February 26, 2026 updated by: Hu Hao, Sixth Affiliated Hospital, Sun Yat-sen University

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Sixth Affiliated Hospital, Sun Yat-sen University, approved by the institutional ethics committee and compliant with the Helsinki Declaration. The study period is January 1, 2023-June 30, 2025; 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 (PNEC) 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

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
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospial, Sun Yat-sen University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 400 enrolled neonates with necrotizing enterocolitis (NEC), with data collected at The Sixth Affiliated Hospital, Sun Yat-sen University from January 2023 to June 2025.

Description

Inclusion Criteria:

  • (1) Diagnosis of NEC and having undergone surgical treatment, confirmed by clinical manifestations (e.g., abdominal distension, bloody stools), radiological evidence (pneumatosis intestinalis, portal venous gas, or pneumoperitoneum), and pathological examination in accordance with established guidelines; (2) Availability of complete medical records for data extraction.

Exclusion Criteria:

  • (1) Congenital gastrointestinal malformations (e.g., intestinal atresia, Hirschsprung's disease) or spontaneous intestinal perforation; (2) Hereditary metabolic disorders; (3) Incomplete clinical data or 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
NIP group
non-intestinal perforation in surgical NEC
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.
PNEC group
Perforated necrotizing enterocolitis
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hu Hao, Doctor, Sixth Affiliated Hospital, Sun Yat-sen University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EK-NEC20250701
  • 2025A1515012514 (Other Grant/Funding Number: Natural Science Foundation of Guangdong Province)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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