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NCT07207915: ACLPNEC
Analysis of Integrated Clinical, Laboratory and Prognostic Data of Neonates With Necrotizing Enterocolitis
trial testing Observational retrospective cohort study in Necrotizing Enterocolitis in 400 participants. Completed in 18 September 2025.
30 June 2025
Quick facts
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 1 January 2023 |
| Primary completion | 30 June 2025 |
| Estimated completion | 18 September 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Observational retrospective cohort study
Conditions studied
- Necrotizing Enterocolitis — all drugs for Necrotizing Enterocolitis →
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Who can join
Adults 1 Day to 3 Months, any sex, with Necrotizing Enterocolitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07207915
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Related trials
Other trials of Observational retrospective cohort study
Trials testing the same drug.
- NCT07249697 — Risk Factors for Poor Prognosis in Neonatal Necrotizing Enterocolitis · completed
Other recruiting trials for Necrotizing Enterocolitis
Currently open trials in the same condition.
- NCT06681129 — Study of Normal Intestinal Development and Disease in Premature and Term Neonates · recruiting
- NCT06672913 — Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study · NA · recruiting
- NCT06908239 — Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants · NA · active not recruiting
- NCT06032676 — Qualitative Study of Surgeons With Prospective Patient Follow-up · recruiting
- NCT05272579 — PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants · EARLY_PHASE1 · recruiting
Other Sixth Affiliated Hospital, Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07538284 — MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) · Phase 2, PHASE3 · not yet recruiting
- NCT07176182 — Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression · Phase 2 · not yet recruiting
- NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response · Phase 4 · recruiting
- NCT07344428 — Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease: A Randomized Trial · NA · not yet recruiting
- NCT07328958 — Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic A · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07207915 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sixth Affiliated Hospital, Sun Yat-sen University
- Last refreshed: 2 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07207915.
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