Analysis of Integrated Clinical, Laboratory and Prognostic Data of Neonates With Necrotizing Ente… (NCT07207915) | Clinical Trial Compass
CompletedNot Applicable
Analysis of Integrated Clinical, Laboratory and Prognostic Data of Neonates With Necrotizing Enterocolitis
China400 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range
1 Day – 3 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already been completed and was tracking outcomes like bowel perforation and in-hospital mortality in newborns with NEC, has my baby's care team seen or reviewed any findings from this type of research that might inform how they're approaching our situation?
2This study focused on analyzing clinical and laboratory data together to better understand NEC — can you explain what laboratory markers or clinical signs you're currently using to assess how severe my baby's NEC is, and whether newer prognostic tools are influencing your decisions?
3Because this was an observational study rather than a treatment trial, it wasn't testing a new therapy — so what are the current standard-of-care treatment options you're recommending for my baby's NEC, and is there a separate interventional trial we should be considering alongside standard treatment?
4The trial specifically tracked in-hospital mortality as a primary outcome, which is frightening to hear — can you walk me through what signs you're watching for that would indicate my baby's condition is worsening, and at what point surgical intervention becomes something you'd recommend?
5Since this study collected integrated data to identify prognostic patterns in NEC, are there any findings from completed research like this that have changed how your team monitors or predicts outcomes for babies like mine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of perforated necrotizing enterocolitis
Timeframe: Day 1 up to 3 months
2
In-hospital mortality
Timeframe: Day 1 up to 3 months
Trial details
NCT IDNCT07207915
SponsorSixth Affiliated Hospital, Sun Yat-sen University