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PICO
Question: Among very young children with sickle cell disease, can hydroxyurea diminish splenic and kidney dysfunction and disease complications?
Question type: Intervention
Study design: Randomized, double-blind, placebo-controlled
Investigators from 13 United States centers conducted the Pediatric Hydroxyurea in Sickle Cell Anemia (BABY HUG) study. In this randomized controlled trial, investigators evaluated the effect of hydroxyurea (HU) (hydroxycarbamide) on the natural history of early splenic and renal dysfunction in children with either hemoglobin SS (HbSS) or hemoglobin Sβ0thalassemia. Eligible patients, 9 to 18 months old at enrollment, were randomized to receive liquid HU at 20 mg/kg/day or placebo for two years. The primary outcomes were splenic function (as measured by qualitative uptake on 99Tc spleen scan) and glomerular filtration rate (GFR). Secondary endpoints included assessments of safety, adverse clinical events, blood counts, fetal hemoglobin, …
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