CLINICAL TRIAL: BABY HUG

临床试验：婴儿拥抱

• 批准号: 7951425
• 负责人: SOHAIL RANA
• 金额: $ 8.89万
• 依托单位: HOWARD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951425
• 关键词: Child; Childhood; Clinic Visits; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Consent; Enrollment; Funding; Grant; Institution; Phase III Clinical Trials; Pilot Projects; Randomized; Research; Research Personnel; Resources; Source; United States National Institutes of Health; Universities; double-blind placebo controlled trial; follow-up; hydroxyurea; treatment duration

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 儿科羟基脲III期临床试验；对幼儿进行羟基脲治疗的随机双盲安慰剂对照试验。该研究之前将进行为期两年的内部试点研究。 所有参加内部试点研究和主要研究的儿童都将接受为期 104 周的研究治疗。内部试点研究中的所有儿童都将受到跟踪，直到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影响。研究治疗结束后，将在研究治疗结束后的 3、6、9、12、16、20、24 和 30 个月以及此后每六个月一次，持续五年内继续进行后续门诊就诊，需要重新获得同意。