PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIAL

婴儿拥抱是一项随机、双盲、安慰剂对照试验，旨在确定羟基尿素是否可以预防患有镰状细胞性贫血的幼儿慢性终末器官损害的发病。在婴儿拥抱之前，另外两项镰状细胞疾病试验成功完成，即镰状细胞性贫血(MSH)中羟基尿素的多中心研究和儿科羟基尿素(PED HUG)试验。大约200名患有镰状细胞病的6个月到24个月大的儿童将被招募接受羟基尿素或安慰剂。这些儿童将在试验启动时进行筛查，看是否有脑、肾、肺和脾功能异常的迹象，以及是否有发育里程碑。然后，他们将被随机分配接受羟基尿素或安慰剂，随后每年对主要器官系统的慢性终末器官损伤进行研究。

BABY HUG is a randomized, double-blind, placebo-controlled trial to determine if hydroxyurea can prevent the onset of chronic end organ damage in young children with sickle cell anemia. BABY HUG follows the successful completion of two other sickle cell disease trials, the Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH) and the Pediatric Hydroxyurea (PED HUG) Trial. Approximately 200 children, ages six months to 24 months, with sickle cell disease will be recruited to receive either hydroxyurea or placebo. The children will be screened at trial start-up for signs of abnormal brain, renal, pulmonary, and splenic function, and for developmental milestones. They will then be randomly assigned to receive hydroxyurea or a placebo and followed with yearly studies of chronic end organ damage of the major organ systems.