NCT00005933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 5, 2000

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

July 1, 2005

First QC Date

July 4, 2000

Last Update Submit

March 3, 2008

Conditions

Keywords

Chronic DiseasePediatricPulmonaryIntelligenceCopingChronic IllnessLearning

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of a confirmed diagnosis of CGD or other phagocytic disorder.
  • Age 2 or older.
  • English spoken in the home.

You may not qualify if:

  • Unconfirmed phagocytic disorder.
  • Under age 2.
  • First language is other than English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Batshaw ML. Mental retardation. Pediatr Clin North Am. 1993 Jun;40(3):507-21. doi: 10.1016/s0031-3955(16)38547-9.

    PMID: 8493062BACKGROUND
  • Boyle IR, di Sant'Agnese PA, Sack S, Millican F, Kulczycki LL. Emotional adjustment of adolescents and young adults with cystic fibrosis. J Pediatr. 1976 Feb;88(2):318-26. doi: 10.1016/s0022-3476(76)81011-6.

    PMID: 1249700BACKGROUND
  • Eliez S, Reiss AL. Genetics of childhood disorders: XI. Fragile X syndrome. J Am Acad Child Adolesc Psychiatry. 2000 Feb;39(2):264-6. doi: 10.1097/00004583-200002000-00029. No abstract available.

    PMID: 10673840BACKGROUND

MeSH Terms

Conditions

Chediak-Higashi SyndromeGranulomatous Disease, ChronicJob SyndromeLeukocyte DisordersChronic Disease

Condition Hierarchy (Ancestors)

AlbinismEye Diseases, HereditaryEye DiseasesPhagocyte Bactericidal DysfunctionHematologic DiseasesHemic and Lymphatic DiseasesPrimary Immunodeficiency DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System DiseasesGenetic Diseases, X-LinkedDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 4, 2000

First Posted

July 5, 2000

Study Start

June 1, 2000

Study Completion

July 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-07

Locations