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NCT00890396 · ClinicalTrials.gov registry record
Long-Term Effects of Hydroxyurea in Children With Sickle Cell Anemia (The BABY HUG Follow-up Study)
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 163
- Enrollment target
NCT00890396: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00890396 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 163 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00890396 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 163 participants
- Enrollment target
Study Summary
Sickle cell anemia (SCA) is an inherited blood disorder that can cause organ damage. The BABY HUG study is evaluating the use of the medication hydroxyurea at preventing organ damage in children with SCA. The purpose of this follow-up study is to evaluate the long-term effects of hydroxyurea in children who have participated in the BABY HUG study.
Primary Outcome
The change in splenic function from the randomized control trial baseline measurement was one of the primary outcomes. The change in splenic function (worse vs not-worse) was compared between the randomized treatment groups (hydroxyurea vs placebo). The change in splenic function from baseline to 48 months was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, decreased to normal, a
Interventions
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2008-09 |
| Est. Completion | 2011-12 |
What the finished NCT00890396 record still lists
NCT00890396 is an observational study that tracks outcomes without assigning an intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Hydroxyurea is the first listed.
NCT00890396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00890396 about?
NCT00890396 is a clinical study titled "Long-Term Effects of Hydroxyurea in Children With Sickle Cell Anemia (The BABY HUG Follow-up Study)". Sickle cell anemia (SCA) is an inherited blood disorder that can cause organ damage. The BABY HUG study is evaluating the use of the medication hydroxyurea at preventing organ damage in children with SCA. The purpose of this follow-up study is to evaluate the long-term effects of hydroxyurea in chil...
What is the current status of trial NCT00890396?
This trial is currently completed. The enrollment target is 163 participants. The study started on 2008-09. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00890396?
The interventions under investigation include: Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT00890396?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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