NCT02551081 Genomic Sequencing and Personalized Treatment for Birth Defects in Neonatal Intensive Care Units
| NCT ID | NCT02551081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Genetic Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2015-10-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2015-10-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: One of the following criteria required. 1. Neonates admitted to the Neonatal Intensive Care Units in one of the study hospitals 2. Clinical genetic testing or a genetic consult is ordered 3. Subject has one major structural anomaly or three or more minor anomalies 4. Abnormal laboratory testing suggestive of a genetic disease 5. Abnormal response to standard therapy for a major underlying condition Exclusion Criteria: 1. Previously performed exome/genome sequencing on patient 2. Any infant in which clinical considerations preclude drawing 1.0 ml of blood 3. Has features pathognomonic for a large chromosomal aberration (Trisomy 13, 18, 21 or other) 4. Parents are unwilling to have genomic reports placed in the medical record or sent to their primary care pediatrician 5. Parents refuse consent
Contact & Investigator
Wenhao Zhou, Doctor
✉ zwhchfu@126.comWenhao Zhou, Doctor
STUDY CHAIR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT02551081 clinical trial?
This trial is open to participants of all sexes, up to 28 Days, studying Genetic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02551081 currently recruiting?
Yes, NCT02551081 is actively recruiting participants. Contact the research team at zwhchfu@126.com for enrollment information.
Where is the NCT02551081 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT02551081 clinical trial?
NCT02551081 is sponsored by Children's Hospital of Fudan University. The principal investigator is Wenhao Zhou, Doctor at Children's Hospital of Fudan University. The trial plans to enroll 2,000 participants.