NCT07249697

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 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

July 1, 2017

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

8 years

First QC Date

November 18, 2025

Last Update Submit

February 25, 2026

Conditions

Necrotizing Enterocolitis

Keywords

Necrotizing Enterocolitismortalitybiomarkers

Outcome Measures

Primary Outcomes (2)

  • In-hospital mortality

    In-hospital mortality

    Day 1 up to 3 months

  • Occurrence of perforated necrotizing enterocolitis

    Occurrence of perforated necrotizing enterocolitis

    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

Surgical group

Patients with NEC who underwent surgical treatment

Other: Observational retrospective cohort study

Non-surgical group

Patients with NEC who did not undergo surgical treatment but opted for conservative treatment

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 groupNon-surgical groupSevere NEC groupSurgical 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 118 enrolled neonates with necrotizing enterocolitis (NEC), with data collected at Guangzhou Women and Children's Medical Center between January 2017 and December 2022.

You may qualify if:

  • (1) Diagnosis of NEC;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangdong, Guangdong, 510623, China

Location

Related Publications (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

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

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

July 1, 2017

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)