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NCT01783990 · ClinicalTrials.gov registry record
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 150
- Enrollment target
NCT01783990: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01783990 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01783990 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
Study Summary
The BABY HUG Treatment Study was designed to see if treatment with the drug hydroxyurea (also called HU) in children with sickle cell disease could prevent organ damage, especially in the spleen and kidneys. There was also a chance that treatment could prevent painful crises, lung disease, stroke, and blood infection.
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 (before treatment initiation) to age 10 years (a visit when child turned 10 years old) was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it cha
Interventions
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-12-31 |
What the finished NCT01783990 record still lists
NCT01783990 is an observational study that tracks outcomes without assigning an intervention. The registered 150 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.
NCT01783990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01783990 about?
NCT01783990 is a clinical study titled "Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol". The BABY HUG Treatment Study was designed to see if treatment with the drug hydroxyurea (also called HU) in children with sickle cell disease could prevent organ damage, especially in the spleen and kidneys. There was also a chance that treatment could prevent painful crises, lung disease, stroke, a...
What is the current status of trial NCT01783990?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2012-10. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT01783990?
The interventions under investigation include: Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT01783990?
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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