Necrotizing EnterocolitisRFPNECNCT07249697
Risk Factors for Poor Prognosis in Neonatal Necrotizing Enterocolitis
An observational study of Necrotizing Enterocolitis, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial 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. 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
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Jun 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 118 enrolled neonates with necrotizing enterocolitis (NEC), with data collected at Guangzhou Women and Children's Medical Center between January 2017 and December 2022.
Who may be able to join
- Diagnosis of NEC;
Who cannot join
- Congenital gastrointestinal malformations (e.g., intestinal atresia, Hirschsprung's disease) or spontaneous intestinal perforation;
- Hereditary metabolic disorders;
- refusal of participation.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children's Medical Center
Guangdong, Guangdong, 510623
About this study
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.
Read the detailed description
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- Observational retrospective cohort study
- Keywords
- Necrotizing Enterocolitis, mortality, biomarkers
- Medical subject headings
- Enterocolitis, Necrotizing
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 group | Role | What they receive |
|---|---|---|
| Mild NEC group | Bell's stage I and IIa Receives: Other: Observational retrospective cohort study | |
| Severe NEC group | Bell's stage IIb and III Receives: Other: Observational retrospective cohort study | |
| Surgical group | Patients with NEC who underwent surgical treatment Receives: Other: Observational retrospective cohort study | |
| Non-surgical group | Patients with NEC who did not undergo surgical treatment but opted for conservative treatment Receives: Other: Observational retrospective cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
In-hospital mortality
Measured: Day 1 up to 3 months
Occurrence of perforated necrotizing enterocolitis
Occurrence of perforated necrotizing enterocolitis
Measured: Day 1 up to 3 months
Secondary outcomes (2)
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
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.
- First posted25 Nov 2025
- Study start1 Jul 2017
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhou, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249697
- Sponsor's protocol ID
- EK-NEC20240705
- Acronym
- RFPNEC
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 32433511Kim 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 32855507Roberts 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 38564081Wang 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 36535423Kislal 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 37794545El-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 32336643Li 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 39905329Lewis 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Poor Prognosis in Neonatal Necrotizing Enterocolitis
- ClinicalTrials.gov ID
- NCT07249697
- Acronym / sponsor ID
- RFPNEC / EK-NEC20240705
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Necrotizing Enterocolitis, mortality, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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).
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild NEC group | – | Other: Observational retrospective cohort studyBell's stage I and IIa |
| Severe NEC group | – | Other: Observational retrospective cohort studyBell's stage IIb and III |
| Surgical group | – | Other: Observational retrospective cohort studyPatients with NEC who underwent surgical treatment |
| Non-surgical group | – | Other: Observational retrospective cohort studyPatients with NEC who did not undergo surgical treatment but opted for conservative treatment |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of NEC;
Key exclusion criteria (3 listed)
- Congenital gastrointestinal malformations (e.g., intestinal atresia, Hirschsprung's disease) or spontaneous intestinal perforation;
- Hereditary metabolic disorders;
- refusal of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational retrospective cohort studyObservational retrospective cohort study, data collection was performed via structured extraction from electronic medical records: Includingclinical characteristics, metabolic indicators, laboratory parameters, prognosis, and outcomes. | Other | Mild NEC group, Non-surgical group, Severe NEC group, Surgical group |
Primary outcome
In-hospital mortality
Time frame: Day 1 up to 3 months
In-hospital mortality
Occurrence of perforated necrotizing enterocolitis
Time frame: Day 1 up to 3 months
Occurrence of perforated necrotizing enterocolitis
2 secondary outcomes
Bell's Staging System for Necrotizing Enterocolitis (NEC)
Time frame: Day 1 up to 3 months
Incidence of Surgical Necrotizing Enterocolitis (NEC)
Time frame: Day 1 up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Results publication: PubMed 32433511Clyman 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.
- Results publication: PubMed 32855507Kim 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.
- Results publication: PubMed 38564081Roberts 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.
- Results publication: PubMed 36535423Wang 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.
- Results publication: PubMed 37794545Kislal 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.
- Results publication: PubMed 32336643El-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.
- Results publication: PubMed 39905329Li 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.
- Results publication: PubMed 35313308Lewis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis, run by Guangzhou Women and Children's Medical Center 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 3 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 27 Feb 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?
In-hospital mortality (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 NCT07249697, which also lists 8 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 27 Feb 2026.