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

Recruitingn/aAges any - 28 DaysAllChildren's Hospital of Fudan University
NCT02551081 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Children Hospital of Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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