BABY HUG

婴儿拥抱

• 批准号: 7607822
• 负责人: SOHAIL RANA
• 金额: $ 1.22万
• 依托单位: HOWARD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7607822
• 关键词: Adherence; Child; Childhood; Chronic; Clinic Visits; Computer Retrieval of Information on Scientific Projects Database; Consent; Creatinine; DNA; Daily; Development; Drug Kinetics; Enrollment; Fetal Hemoglobin; Funding; Glomerular Filtration Rate; Gold; Grant; Growth and Development function; Height; Institution; Intraobserver Variability; Liver; Oral; Organ; Pentetic Acid; Phase III Clinical Trials; Pilot Projects; Procedures; Randomized; Reading; Research; Research Personnel; Resources; Safety; Scanning; Schedule; Serum; Sickle Cell Anemia; Source; Spleen; Standards of Weights and Measures; Toxic effect; Unexpected Adverse Event; United States National Institutes of Health; Week; age group; base; compliance behavior; double-blind placebo controlled trial; follow-up; hydroxyurea; neuropsychological; response; 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. OBJECTIVES: Objectives of the Internal Pilot Study: 1. To determine the feasibility of BABY HUG in terms of recruitment, follow-up, adherence to study treatment, and compliance with the study schedule of procedures. 2. To assess Hydroyurea toxicity, effect on growth and development, and occurrence of severe/unexpected adverse events. 3. To establish the distribution and inter-observer and intra-observer variability of spleen function based on dual, independent readings of liver-spleen scans. 4. To evaluate the validity and variability of glomerular filtration rate (GFR) as estimated by serum creatinine and height (the Schwartz formula) compared with a "gold standard" such as DTPA clearance. 5. to assess some pharmacokinetics parametes of Hydroxyurea can reduce in the BABY HUG age group. Objective of the Main Study: 1. To determine whether daily oral Hydroxyurea can reduce by /=50% chronic organ damage that develops in young children with sickle cell anemia. 2. To determine the relationship between fetal hemoglobin (HbF) levels and chronic organ damage in young children with sickle cell anemia. 3. To investigate the safety of Hydroxyurea for young children with sickle cell anemia regarding a. physcial growth and development, b. neuropsychological development, c. immunological responses, and d. mutagenic effects on DNA.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 小儿羟基脲III期临床试验；非常年幼的羟基脲治疗的随机双盲安慰剂对照试验。该研究将在一项为期两年的内部试点研究之前。 所有参加内部试点研究和主要研究的孩子将在104周内接受研究治疗。内部试点研究中的所有儿童将被遵循，直到最后一个儿童的研究治疗以终止研究治疗的不良影响的观察结束。研究治疗结束后，将要求续签同意，在研究待遇结束后的3、6、9、12、16、20、24和30个月内进行持续的随访诊所就诊，此后每六个月最多五年。 目标： 内部试点研究的目标： 1。确定婴儿拥抱在招聘，随访，遵守研究治疗方面的可行性以及遵守研究时间表。 2。评估羟基脲的毒性，对生长和发育的影响以及发生严重/意外的不良事件的发生。 3。建立基于肝脏扫描的双重独立读数的脾脏功能的分布和观察者间和观察者内的变异性。 4。与“金标准”（例如DTPA清除率）相比，通过血清肌酐和高度（Schwartz公式）估计的肾小球滤过率（GFR）的有效性和变异性。 5。评估一些羟基脲的药代动力学参数可以减少婴儿拥抱年龄组。 主要研究的目的： 1。确定每日口腔羟基脲是否可以减少 /= 50％的慢性器官损伤，这会在患有镰状细胞贫血的幼儿造成。 2。确定镰状细胞性贫血儿童的胎儿血红蛋白（HBF）水平与慢性器官损害之间的关系。 3。调查羟基脲对镰状细胞贫血的幼儿的安全性 一个。物理增长和发展， b。神经心理学发展， c。免疫反应和 d。对DNA的诱变作用。