NCT07207915

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

September 21, 2025

Last Update Submit

February 26, 2026

Conditions

Necrotizing Enterocolitis

Keywords

necrotizing enterocolitisLactateIntestinal perforationMortalitynSOFA

Outcome Measures

Primary Outcomes (2)

  • Occurrence of perforated necrotizing enterocolitis

    Occurrence of perforated necrotizing enterocolitis

    Day 1 up to 3 months

  • In-hospital mortality

    In-hospital mortality

    Day 1 up to 3 months

Secondary Outcomes (2)

  • Bell's Staging System for Necrotizing Enterocolitis (NEC)

    Day 1 up to 3 months

  • Incidence of Surgical Necrotizing Enterocolitis (NEC)

    Day 1 up to 3 months

Study Arms (4)

Mild NEC group

Bell's stage I and IIa

Other: Observational retrospective cohort study

Severe NEC group

Bell's stage IIb and III

Other: Observational retrospective cohort study

NIP group

non-intestinal perforation in surgical NEC

Other: Observational retrospective cohort study

PNEC group

Perforated necrotizing enterocolitis

Other: Observational retrospective cohort study

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.

Mild NEC groupNIP groupPNEC groupSevere NEC group

Eligibility Criteria

Age1 Day - 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sixth Affiliated Hospial, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (16)

  • 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.

    PMID: 35313308RESULT

  • 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.

    PMID: 39905329RESULT

  • 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.

    PMID: 32336643RESULT

  • 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.

    PMID: 37794545RESULT

  • 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.

    PMID: 36535423RESULT

  • 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.

    PMID: 38564081RESULT

  • 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.

    PMID: 32855507RESULT

  • 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.

    PMID: 32433511RESULT

  • 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.

    PMID: 19524719RESULT

  • 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.

    PMID: 22929145RESULT

  • 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.

    PMID: 39834496RESULT

  • 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.

    PMID: 35008115RESULT

  • 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.

    PMID: 38955846RESULT

  • 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.

    PMID: 36200375RESULT

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

    PMID: 30864508RESULT

  • Jiang S, Yan W, Li S, Zhang L, Zhang Y, Shah PS, Shah V, Lee SK, Yang Y, Cao Y. Mortality and Morbidity in Infants <34 Weeks' Gestation in 25 NICUs in China: A Prospective Cohort Study. Front Pediatr. 2020 Feb 13;8:33. doi: 10.3389/fped.2020.00033. eCollection 2020.

    PMID: 32117838RESULT

MeSH Terms

Conditions

Enterocolitis, NecrotizingIntestinal Perforation

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Hu Hao, Doctor

    Sixth Affiliated Hospital, Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2025

First Posted

October 6, 2025

Study Start

January 1, 2023

Primary Completion

June 30, 2025

Study Completion

September 18, 2025

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)