Caffeine for Hypoxic Ischemic Encephalopathy
报名条件（概要）
- 年龄：不限 – 6 Hours
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
Bangladesh、Democratic Republic of the Congo、Guatemala、India、Pakistan、Zambia
药品与企业信息
Caffeine citrate oral solution will be used and administered by enteral route (oral or by gavage tube). The loading dose (20 mg/kg) will be administered once followed by daily doses of 10 mg per kg body weight every 24 hours for two doses. The study Standard Operating Procedures (SOPs) includes details regarding caffeine preparation based on the participant's body weight.
其他名称：Oral placebo
Identical placebo oral solution
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
合作机构
- RTI International研究机构/其他
- University of North Carolina, Chapel Hill研究机构/其他
- Kinshasa School of Public Health研究机构/其他
- Institute of Nutrition of Central America and Panama研究机构/其他
- Lata Medical Research Foundation, Nagpur研究机构/其他
- Aga Khan University研究机构/其他
- University Teaching Hospital, Lusaka, Zambia研究机构/其他
- KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, IndiaUNKNOWN
- Bill and Melinda Gates Foundation研究机构/其他
- University of Virginia研究机构/其他
- University of Alabama at Birmingham研究机构/其他
- Thomas Jefferson University研究机构/其他
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE). The trial will recruit neonates who are diagnosed with HIE within six hours after birth based on physiologic criteria (acidosis noted on an umbilical cord or early \[\<1 hour\] postnatal blood sample) and neurologic criteria (modified Sarnat exam consistent with encephalopathy). Following informed consent, and by six hours after birth, neonates with HIE will be randomized to one of two treatment arms and subsequently receive one 20 mg/kg dose of oral caffeine followed by two additional 10 mg/kg doses at 24-hour intervals or placebo of the same regimen (three total doses). The goal of this clinical trial is to compare the incidence of all-cause mortality OR moderate to severe neurodevelopmental impairment (NDI) at 18-22 months between neonates with HIE who are randomized to oral caffeine or placebo. Our hypothesis is that neonates with HIE who receive oral caffeine will have 10% lower incidence of all-cause mortality or moderate to severe NDI at 18-22 months compared to placebo.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Laura Danielle Wagner, MPHwagner@rti.org+1-919-541-6000
- Jennifer J Hemingway-Foday, MPH, MSWhemingway@rti.org
研究中心联系方式
- ICDDR,BSaidpur，Bangladesh
- Kinshasa School of Public HealthKinshasa，Democratic Republic of the Congo
- Institute of Nutrition of Central America And Panama (INCAP)Chimaltenango，Guatemala
- KLE University's J N Medical CollegeBelagavi，India
- Lata Medical Research FoundationNagpur，India
- Aga Khan UniversityKarachi，Pakistan
问自己是否符合条件、如何预筛
我的病情档案
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Caffeine for Hypoxic Ischemic Encephalopathy ClinicalTrials.gov Identifier: NCT06855108 Sponsor: NICHD Global Network for Women's and Children's Health Investigational product: Caffeine citrate oral solution, Oral placebo solution About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Caffeine for Hypoxic Ischemic Encephalopathy 试验编号：NCT06855108 申办方：NICHD Global Network for Women's and Children's Health 研究药物：Caffeine citrate oral solution、Oral placebo solution 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。