Pediatric Primary Immunodeficiency Disease (PID) in China
Clinical Characteristics and Prognosis of Primary Immunodeficiency Disease (PID) in Chinese Children
1 other identifier
observational
400
0 countries
N/A
Brief Summary
This study is a prospective cohort study of children diagnosed with primary immunodeficiency disease (PID). The aim is to investigate the clinical characteristics and prognosis of PID in Chinese children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 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
August 15, 2017
CompletedFirst Posted
Study publicly available on registry
August 17, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJanuary 3, 2018
May 1, 2017
4.6 years
August 15, 2017
January 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Frequencies of severe infection of children with PID
Times of severe infection attack will be recorded every year from baseline to 60 months, assessed by questionnaire
60 months
Secondary Outcomes (3)
Life quality of children with PID
60 months
Complications of children with PID
60 months
Long-term changes on lung function of children with PID
60 months
Eligibility Criteria
Children who was confirmed diagnosis as PID at the certain hospitals
You may qualify if:
- Age: from neonates to 18 years old
- Fulfilling the one of the followings:
- Severe infection after vaccination (BCG, polio arthritis pill)
- Chronic/recurrent ear infection, sinus infections and respiratory tract infection
- Recurrent, deep skin or deep-seated infections
- Boys with early period and refractory thrombocytopenia
- Infants with obviously decreased absolute number of lymphocytes
- Severe allergy with infection
- Infant diabetes with severe diarrhea
- Boys with severe Epstein-Barr virus infection
- Infants with hepatosplenomegaly and generalized lymphadenopathy
- Infantile hemophagocytic syndrome
- Failure of an infant to gain weight or grow normally
- Persistent thrush in mouth or fungalinfection on skin
- Family history of primary immunodeficiency
- +3 more criteria
You may not qualify if:
- Subject will be excluded if she or he would not enroll into this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Children's Hospitallead
- Capital Institute of Pediatrics, Chinacollaborator
- Shenzhen Children's Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
kunling shen, MD,PhD
Beijing Children's Hospital, Capital Medical University, China
- PRINCIPAL INVESTIGATOR
jianxin he, MD,PhD
Beijing Children's Hospital, Capital Medical University, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of China National Clinical Research Center for Respiratory Diseases
Study Record Dates
First Submitted
August 15, 2017
First Posted
August 17, 2017
Study Start
January 1, 2018
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
January 3, 2018
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share