NCT01783990

Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: 24 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The current observational trial, Follow-Up Study ((FUS) II includes enhanced neuropsychological, brain, cardiac, and pulmonary evaluations for this very well characterized cohort of subjects. Measures of spleen and renal function and markers of DNA damage will continue to be collected. Assessment of other target organs in sickle cell disease including pulmonary and cardiac function will be performed in addition to evaluation of developmental aspects of sickle cell disease (SCD) and potential HU toxicity.

Conditions

• Sickle Cell Anemia

Interventions

Type	Name	Description
DRUG	Hydroxyurea	Parents and child's doctor may plan to use or not to use hydroxyurea.

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2013-02-05
• Last updated: 2020-08-20
• Results posted: 2020-08-20

Locations

14 sites across 1 country: United States