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NCT05416918
Clinical Value of Metagenomic Sequencing in Neonatal Sepsis
trial in Neonatal Sepsis in 200 participants. Completed in 30 December 2022.
1 December 2022
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 1 April 2022 |
| Primary completion | 1 December 2022 |
| Estimated completion | 30 December 2022 |
| Sites | 1 location across China |
Conditions studied
- Neonatal Sepsis — all drugs for Neonatal Sepsis →
Sponsor
Children's Hospital of Fudan University
Who can join
Adults 0 Days to 28 Days, any sex, with Neonatal Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aimed to enroll 2000 neonatal patients with suspected sepsis or clinical diagnosed sepsis. These patients will undergo both conventional methods and metagenomics sequencing to detect the pathogenic microorganisms of sepsis. The purpose of this study was to assess the clinical value of metagenomics sequencing for the diagnosis and treatment of neonatal sepsis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Molecular assays for the diagnosis of sepsis in neonates: a diagnostic test accuracy review.
Dierikx TH, Visser DH, de Meij T, Versalovic J, et al · · 2025 · cited 3× · PMID 40105375 · DOI 10.1002/14651858.cd011926.pub3
Verify or expand the search:
- PubMed search for NCT05416918
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neonatal Sepsis
Currently open trials in the same condition.
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- NCT06592586 — A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women · Phase 2, PHASE3 · active not recruiting
Other Children's Hospital of Fudan University trials
Trials by the same sponsor.
- NCT04955821 — Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS · not yet recruiting
- NCT05862688 — A Cohort Study on Anti-microbial Stewardship in PICU · not yet recruiting
- NCT05595239 — Blood Purification in Septic Children · NA · not yet recruiting
- NCT07325903 — Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty · EARLY_PHASE1 · not yet recruiting
- NCT07141615 — Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of P · NA · not yet 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 NCT05416918 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Fudan University
- Last refreshed: 28 December 2023
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/NCT05416918.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing