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NCT02551081
Genomic Sequencing and Personalized Treatment for Birth Defects in Neonatal Intensive Care Units
trial in Genetic Disease in 2,000 participants. Currently enrolling.
30 December 2025
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 2,000 |
| Start date | 1 October 2015 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across China |
Conditions studied
- Genetic Disease — all drugs for Genetic Disease →
- Multiple Malformation — all drugs for Multiple Malformation →
- Congenital Malformation — all drugs for Congenital Malformation →
Sponsor
Children's Hospital of Fudan University
Who can join
Under 28 Days, any sex, with Genetic Disease or Multiple Malformation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of study is to evaluate the benefits of using the Next Generation Sequencing Technology to diagnose birth defects and genetic diseases. The results from genomic sequencing can also significantly shorten the time of examination, improve the diagnosis rate, guide the clinical treatments. So the ultimate goal is individualized or personalized therapy and promote prognosis.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Feeding difficulty is the dominant feature in 12 Chinese newborns with CHD7 pathogenic variants.
Chen X, Yan K, Gao Y, Wang H, et al · · 2019 · cited 7× · PMID 31146700 · DOI 10.1186/s12881-019-0813-z -
Precision medicine via the integration of phenotype-genotype information in neonatal genome project.
Dong X, Xiao T, Chen B, Lu Y, et al · · 2022 · cited 6× · PMID 38933389 · DOI 10.1016/j.fmre.2022.07.003 -
High-risk phenotypes of genetic disease in a Neonatal Intensive Care Unit population.
Xiao T, Ni Q, Chen H, Wang H, et al · · 2022 · cited 1× · PMID 35026772 · DOI 10.1097/cm9.0000000000001959
Verify or expand the search:
- PubMed search for NCT02551081
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Genetic Disease
Currently open trials in the same condition.
- NCT06744543 — Clinical Decision Support to Identify Pediatric Patients With Undiagnosed Genetic Disease · NA · active not recruiting
- NCT06435468 — Biocollection of Rare Pediatric-onset of Autoimmune and Autoinflammatory Diseases · NA · recruiting
- NCT06821386 — N-Care Project: Enhancing Asian-Pacific Collaboration · recruiting
- NCT07365254 — Accurate Assessment and Intervention Research on Newborn Whole Genome Sequencing and Genetic Disease Risk · recruiting
- NCT06725901 — Pediatric Neurogenetic Diagnosis Support Platform · NA · 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 NCT02551081 (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: 5 September 2025
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/NCT02551081.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing