CLINICAL TRIAL: BABY HUG

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 小儿羟基脲III期临床试验;一项在极年幼儿童中进行的羟基脲治疗的随机、双盲、安慰剂对照试验。在研究之前，将进行为期两年的内部试点研究。 入组内部初步研究和主研究的所有儿童将接受为期104周的研究治疗。将对内部初步研究中的所有儿童进行随访，直至最后一名儿童的研究治疗结束，并观察停止研究治疗的不良反应。研究治疗结束后，将在研究治疗结束后3、6、9、12、16、20、24和30个月以及此后每6个月一次，持续5年，要求重新签署同意书以继续进行随访门诊访视。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Pediatric Hydroxyurea Phase III Clinical Trial; a Randomized Double-blind Placebo Controlled Trial of Hydroxyurea Therapy in Very Young Children. The study will be preceded by a two-year Internal Pilot Study. All the children enrolled in the Internal Pilot Study and the main study will receive study treatment for the duration of 104 weeks. All children in the Internal Pilot Study will be followed until the last child's study treatment has ended with observation for untoward effects of discontinuing study treatment. After study treatment ends, renewed consent will be requested for continued follow-up clinic visits at 3, 6, 9, 12, 16, 20, 24, and 30 months after the end of study treatment, and every six months thereafter for up to five years.