Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001109
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
1999-11-02
Brief Title:
A Blood Test to Look at Cells of the Immune System in Healthy Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Mononuclear Cell Phenotyping in Normal Children
Status:
COMPLETED
Status Verified Date:
2004-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn more about some of the immune cells in the blood CD4 cells for example of healthy children in order to better understand the differences in the blood cells of children infected with HIV
Because childrens bodies are still developing their cells are different from those of adults and their bodies respond differently to infections such as HIV In order to understand how immune cells grow and mature so that they can fight HIV it is important to see how these cells behave in normal children
Because childrens bodies are still developing their cells are different from those of adults and their bodies respond differently to infections such as HIV In order to understand how immune cells grow and mature so that they can fight HIV it is important to see how these cells behave in normal children
Detailed Description:
Early in life the cells involved in immune selection differentiate into CD4 and CD8 cells Currently there is insufficient information on the cell maturation and activation of these peripheral blood mononuclear cell PBMC subsets in normal children The critical need for this information has been brought about by the pediatric HIVAIDS epidemic which requires the measurement of peripheral blood CD4 T cells and other cells types for interpretation of HIV disease progression The immunopathogenesis of pediatric HIV infection differs from that in adults but is not well understood In order to better understand HIV disease progression in HIV-infected children these PBMC subsets must be studied in normal children so that control values can be established
Healthy infants children and adolescents presenting for routine care or elective surgery have a single blood sample obtained Blood is used for complete blood count peripheral blood mononuclear cell flow analysis for surface markers and plasma and cell storage Demographic information including age sex race and ethnicity is obtained at the time of the blood draw The reason for the patients visit is also documented No study drugs are administered or supplied as part of this study Statistical analysis is used to estimate the median distribution of each CD4 and CD8 subset
Healthy infants children and adolescents presenting for routine care or elective surgery have a single blood sample obtained Blood is used for complete blood count peripheral blood mononuclear cell flow analysis for surface markers and plasma and cell storage Demographic information including age sex race and ethnicity is obtained at the time of the blood draw The reason for the patients visit is also documented No study drugs are administered or supplied as part of this study Statistical analysis is used to estimate the median distribution of each CD4 and CD8 subset
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PACTG P1009 | None | None | None |