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Necrotizing EnterocolitisACLPNECNCT07207915

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

An observational study of Necrotizing Enterocolitis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 3 monthsHealthy volunteers can take part
Conditions the study is for
Necrotizing Enterocolitis
What is being tested?
Observational retrospective cohort study
How many people
400 participants
Where
1 siteChina
Study dates
1 Jan 2023to 18 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 3 months
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • (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.

Who cannot join

  • (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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Sixth Affiliated Hospial, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

Other trials in China

About this study

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.

Read the 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.
Being tested
Observational retrospective cohort study
Keywords
necrotizing enterocolitis, Lactate, Intestinal perforation, Mortality, nSOFA
Medical subject headings
Enterocolitis, Necrotizing, Intestinal Perforation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07207915
Study groupRoleWhat they receive
Mild NEC groupBell's stage I and IIa
Receives: Other: Observational retrospective cohort study
Severe NEC groupBell's stage IIb and III
Receives: Other: Observational retrospective cohort study
NIP groupnon-intestinal perforation in surgical NEC
Receives: Other: Observational retrospective cohort study
PNEC groupPerforated necrotizing enterocolitis
Receives: Other: Observational retrospective cohort study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of perforated necrotizing enterocolitis

    Occurrence of perforated necrotizing enterocolitis

    Measured: Day 1 up to 3 months

  2. In-hospital mortality

    In-hospital mortality

    Measured: Day 1 up to 3 months

Secondary outcomes (2)

  1. Bell's Staging System for Necrotizing Enterocolitis (NEC)

    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.

    Measured: Day 1 up to 3 months

  2. Incidence of Surgical Necrotizing Enterocolitis (NEC)

    "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.

    Measured: Day 1 up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2025
  2. Study start1 Jan 2023
  3. Primary completion30 Jun 2025
  4. Study completion18 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07207915
Sponsor's protocol ID
EK-NEC20250701
Other IDs
2025A1515012514
Acronym
ACLPNEC
Status last verified
Feb 2026
First submitted
21 Sep 2025
Last updated
2 Mar 2026
Results posted
No
Individual data sharing
No

Publications

  • Lewis AN, de la Cruz D, Wynn JL, Frazer LC, Yakah W, Martin CR, Yang H, Itriago E, Unger J, Hair AB, Miele J, Sullivan BA, Husain A, Good M. Evaluation of the Neonatal Sequential Organ Failure Assessment and Mortality Risk in Preterm Infants with Necrotizing Enterocolitis. Neonatology. 2022;119(3):334-344. doi: 10.1159/000522560. Epub 2022 Mar 21.

    PubMed 35313308

  • Li B, Chen Y, Yang Z, Sun X, Tian C, Liu J, Yuan L, Dai K. Lactate/albumin ratio as a prognostic biomarker for in-hospital mortality in pediatric patients with necrotizing enterocolitis. BMC Pediatr. 2025 Feb 4;25(1):93. doi: 10.1186/s12887-025-05439-5.

    PubMed 39905329

  • El-Abd Ahmed A, Hassan MH, Abo-Halawa N, Abdel-Razik GM, Moubarak FA, Sakhr HM. Lactate and intestinal fatty acid binding protein as essential biomarkers in neonates with necrotizing enterocolitis: ultrasonographic and surgical considerations. Pediatr Neonatol. 2020 Oct;61(5):481-489. doi: 10.1016/j.pedneo.2020.03.015. Epub 2020 Apr 5.

    PubMed 32336643

  • Kislal FM, Polat CC, Ergul E, Acikalin AA, Guven D, Gundogan E, Sarici D. Can lactate be valuable in early diagnosis and prognosis of neonatal sepsis? Niger J Clin Pract. 2023 Sep;26(9):1319-1325. doi: 10.4103/njcp.njcp_54_23.

    PubMed 37794545

  • Wang Y, Lai L, Zhang Q, Zheng L. Lactate acid level and prognosis of neonatal necrotizing enterocolitis: a retrospective cohort study based on pediatric-specific critical care database. J Pediatr (Rio J). 2023 May-Jun;99(3):278-283. doi: 10.1016/j.jped.2022.11.005. Epub 2022 Dec 16.

    PubMed 36535423

  • Roberts AG, Younge N, Greenberg RG. Neonatal Necrotizing Enterocolitis: An Update on Pathophysiology, Treatment, and Prevention. Paediatr Drugs. 2024 May;26(3):259-275. doi: 10.1007/s40272-024-00626-w. Epub 2024 Apr 2.

    PubMed 38564081

  • Kim JH, Sampath V, Canvasser J. Challenges in diagnosing necrotizing enterocolitis. Pediatr Res. 2020 Aug;88(Suppl 1):16-20. doi: 10.1038/s41390-020-1090-4.

    PubMed 32855507

  • Clyman RI, Jin C, Hills NK. A role for neonatal bacteremia in deaths due to intestinal perforation: spontaneous intestinal perforation compared with perforated necrotizing enterocolitis. J Perinatol. 2020 Nov;40(11):1662-1670. doi: 10.1038/s41372-020-0691-4. Epub 2020 May 20.

    PubMed 32433511

  • Fitzgibbons SC, Ching Y, Yu D, Carpenter J, Kenny M, Weldon C, Lillehei C, Valim C, Horbar JD, Jaksic T. Mortality of necrotizing enterocolitis expressed by birth weight categories. J Pediatr Surg. 2009 Jun;44(6):1072-5; discussion 1075-6. doi: 10.1016/j.jpedsurg.2009.02.013.

    PubMed 19524719

  • Sakellaris G, Partalis N, Dede O, Alegakis A, Seremeti C, Korakaki E, Giannakopoulou C. Gastrointestinal perforations in neonatal period: experience over 10 years. Pediatr Emerg Care. 2012 Sep;28(9):886-8. doi: 10.1097/PEC.0b013e31826beb0c.

    PubMed 22929145

  • Chen M, Feng W, Hou J, Die X, Guo Z, Wang Y. Effect of gestational age on clinical features in necrotizing enterocolitis-associated intestinal perforation. Front Pediatr. 2025 Jan 6;12:1452207. doi: 10.3389/fped.2024.1452207. eCollection 2024.

    PubMed 39834496

  • Imren C, Vlug LE, de Koning BAE, Diertens T, Snel HE, Suurland J, Swarte RMC, Vermeulen MJ, Keyzer-Dekker CMG. Necrotizing Enterocolitis in a Dutch Cohort of Very Preterm Infants: Prevalence, Mortality, and Long-Term Outcomes. Eur J Pediatr Surg. 2022 Feb;32(1):111-119. doi: 10.1055/s-0041-1741544. Epub 2022 Jan 10.

    PubMed 35008115

  • Butler V, Treluyer L, Patkai J, Biset A, Jarreau PH, Ancel PY, Roze JC, Marchand-Martin L, Durox M, Lapillonne A, Picaud JC, Mitanchez D, Tscherning C, Biran V, Cambonie G, Lopez E, Hascoet JM, Desfrere L, Chollat C, Zana-Taieb E, Torchin H. Mortality and neurodevelopmental outcomes at 2 years' corrected age of very preterm infants with necrotising enterocolitis or spontaneous intestinal perforation: The EPIPAGE-2 cohort study. Eur J Pediatr. 2024 Sep;183(9):4019-4028. doi: 10.1007/s00431-024-05675-4. Epub 2024 Jul 2.

    PubMed 38955846

  • Vaidya R, Yi JX, O'Shea TM, Jensen ET, Joseph RM, Shenberger J, Gogcu S, Wagner K, Msall ME, Thompson AL, Frazier JA, Fry R, Singh R; ELGAN-ECHO Study Investigators. Long-Term Outcome of Necrotizing Enterocolitis and Spontaneous Intestinal Perforation. Pediatrics. 2022 Nov 1;150(5):e2022056445. doi: 10.1542/peds.2022-056445.

    PubMed 36200375

  • Bazacliu C, Neu J. Necrotizing Enterocolitis: Long Term Complications. Curr Pediatr Rev. 2019;15(2):115-124. doi: 10.2174/1573396315666190312093119.

    PubMed 30864508

Questions about this trial

What is this clinical trial studying?

An observational study of Necrotizing Enterocolitis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of perforated necrotizing enterocolitis (time frame: Day 1 up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07207915, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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