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The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue.
Approximately 134 children and adolescents will be enrolled. All children and adolescents will wear a wrist actigraph for two consecutive 5-day study periods. Children and adolescents will have blood drawn 2 times on Day 1 when they are on dexamethosone. Their parents will complete a sleep diary and fatigue questionnaire by telephone on Days 2 and 5 of both study periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Cycle | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethosone | Drug | 10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue and sleep quality changes | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacogenetics with dextamethasone use | 5 days | |
| Pharmacokinetics with dextamethasone use | 5 days |
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Children and adolescents with Leukemia, both genders
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| Name | Affiliation | Role |
|---|---|---|
| Pamela S Hinds, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children Research Hospital | Memphis | Tennessee | 38105 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D011729 | Pyridostigmine Bromide |
| ID | Term |
|---|---|
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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