Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005933
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-07-04
Brief Title:
Learning and Behavior Problems in Children With Chronic Granulomatous Disease and Related Disorders
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cognitive Function in Leukocyte Disorders
Status:
COMPLETED
Status Verified Date:
2005-07
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:
This study will try to determine what causes learning behavioral and emotional problems in children with chronic granulomatous disease GCD and other phagocyte disorders Phagocytes are a type of white blood cell Children with these disorders have frequent severe infections that require hospitalization sometimes for long periods of time Many of them also have problems with school learning behavior anxiety and depression This study will explore whether these latter problems are a direct result of the illness itself or are a consequence of frequent long hospitalizations or are due to other factors Test findings in these children will be compared with those of children with cystic fibrosis-another disease that causes frequent infections requiring prolonged hospitalization
Patients age 2 or older with GCD or other phagocytic disorders or cystic fibrosis may be eligible for this study Participants or a parent or guardian will complete questionnaires including personal information such as age gender and marital status a family medical history and information on their illness Patients will be given various psychological and intelligence tests and they and their parents or guardians will be interviewed by a child psychiatrist The tests and interviews take a total of about 5 hours and are given in two or three separate sessions
The tests may reveal problems such as learning disorders attention-deficit hyperactivity disorder anxiety or depression If any of these problems are identified appropriate referrals will be made for specialized services such as special school placement tutoring or counseling
Patients age 2 or older with GCD or other phagocytic disorders or cystic fibrosis may be eligible for this study Participants or a parent or guardian will complete questionnaires including personal information such as age gender and marital status a family medical history and information on their illness Patients will be given various psychological and intelligence tests and they and their parents or guardians will be interviewed by a child psychiatrist The tests and interviews take a total of about 5 hours and are given in two or three separate sessions
The tests may reveal problems such as learning disorders attention-deficit hyperactivity disorder anxiety or depression If any of these problems are identified appropriate referrals will be made for specialized services such as special school placement tutoring or counseling
Detailed Description:
Leukocyte disorders are predominantly genetic diseases in which phagocytes fail to function normally resulting in recurrent infections Children with these disorders are subject to recurrent severe often life-threatening infections and are hospitalized more frequently than their peers Frequent hospitalization and chronic illness can affect growth development socialization and educational opportunities
Specifically chronic granulomatous disease CGD is an inherited disorder in which phagocytes fail to generate an oxidative burst In 26 patients followed at the NIH tested for behavioral problems at the request of a parent or staff member we have observed a 23 rate of mild mental retardation However it is not clear whether this is due to CGD per se or the recurrent infections and hospitalizations We seek to determine the prevalence of cognitive disabilities in children with CGD and other leukocyte disorders We seek to determine whether abnormal leukocyte functioning may be related to specific behavioral phenotypes or impaired cognitive functioning We also seek to clarify whether impaired cognitive functioning is related to the effects of frequent and prolonged hospitalization or other variables such as severity of illness in this population
Specifically chronic granulomatous disease CGD is an inherited disorder in which phagocytes fail to generate an oxidative burst In 26 patients followed at the NIH tested for behavioral problems at the request of a parent or staff member we have observed a 23 rate of mild mental retardation However it is not clear whether this is due to CGD per se or the recurrent infections and hospitalizations We seek to determine the prevalence of cognitive disabilities in children with CGD and other leukocyte disorders We seek to determine whether abnormal leukocyte functioning may be related to specific behavioral phenotypes or impaired cognitive functioning We also seek to clarify whether impaired cognitive functioning is related to the effects of frequent and prolonged hospitalization or other variables such as severity of illness in this population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-I-0164 | None | None | None |