NGS in the Diagnosis of Neonatal Diseases
The Application of Targeted Sequencing in the Diagnosis of Neonatal Diseases
1 other identifier
observational
1,800
0 countries
N/A
Brief Summary
To investigate the application of NGS in neonatal disease screening and diagnosis, two studies was conducted (the other ID is: shercru-20220003). This study is to evaluate the application of NGS in the diagnosis of neonatal disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
July 27, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJuly 27, 2022
July 1, 2022
2 years
July 25, 2022
July 26, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Diagnostic time
In each cohort, NGS was conducted to investigate whether NGS can shorten the diagnostic time.
up to 6 months
Prognosis (mortality)
In each cohort, NGS was conducted to investigate whether NGS can reduce the mortality of children.
up to 1 year
Study Arms (6)
conventional NBS+ infants
Disease diagnosis is carried out using conventional diagnosis and treatment methods.
conventional NBS+ infants (NGS)
Disease diagnosis is carried out using conventional diagnosis and treatment methods, as well as NGS.
NICU infants
Disease diagnosis is carried out using conventional diagnosis and treatment methods.
NICU infants (NGS)
Disease diagnosis is carried out using conventional diagnosis and treatment methods, as well as NGS.
Premature infants
Disease diagnosis is carried out using conventional diagnosis and treatment methods.
Premature infants (NGS)
Disease diagnosis is carried out using conventional diagnosis and treatment methods, as well as NGS.
Interventions
In the conbentional NBS+/NICU/premature infants, NGS was conducted to investigate whether NGS can accelerate diagnosis and improve prognosis in these children
Eligibility Criteria
In the cohort of conventional NBS+/ NICU/ premature infants, the corresponding targeted population was included in the study and analysis.
You may qualify if:
- Subjects: conventional NBS+ infants NICU infants premature infants
- After fully understanding the program, the guardian signs the informed consent and agrees to participate in the program.
You may not qualify if:
- Other similar clinical research projects are under way for the examined neonates;
- Neonates have received transfusion of allogeneic blood products;
- Newborns whose guardians explicitly refuse to participate in the program after receiving the mission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lin Zou
Shanghai Children's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2022
First Posted
July 27, 2022
Study Start
August 1, 2022
Primary Completion
August 1, 2024
Study Completion
December 1, 2024
Last Updated
July 27, 2022
Record last verified: 2022-07