Actively Recruiting

Age: 0 - 28Days
All Genders
NCT02551081

Genomic Sequencing and Personalized Treatment for Birth Defects in Neonatal Intensive Care Units

Led by Children's Hospital of Fudan University · Updated on 2025-09-05

2000

Participants Needed

1

Research Sites

534 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital of Fudan University

Lead Sponsor

X

Xiamen Children's Hospital, Fujian of China

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Genomic Sequencing and Personalized Treatment for Birth Defects in Neonatal Intensive Care Units

Who Can Participate

Age: 0 - 28Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Neonates admitted to the Neonatal Intensive Care Units in one of the study hospitals
  • Clinical genetic testing or a genetic consult is ordered
  • Subject has one major structural anomaly or three or more minor anomalies
  • Abnormal laboratory testing suggestive of a genetic disease
  • Abnormal response to standard therapy for a major underlying condition
Not Eligible

You will not qualify if you...

  • Previously performed exome/genome sequencing on patient
  • Any infant in which clinical considerations preclude drawing 1.0 ml of blood
  • Has features pathognomonic for a large chromosomal aberration (Trisomy 13, 18, 21 or other)
  • Parents are unwilling to have genomic reports placed in the medical record or sent to their primary care pediatrician
  • Parents refuse consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

W

Wenhao Zhou, Doctor

CONTACT

G

Guoqiang Cheng, Doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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