Supine vs Prone Position at Birth Before Cord Clamping A Randomized Controlled Trial
赞助:
Maisonneuve-Rosemont Hospital
合作者:
信息的提供 (责任方):
Dr Brahim Bensouda，Maisonneuve-Rosemont Hospital
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 4, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | November 1, 2018 | ||
| 预计主要完成日期 | November 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Hemoglobin[ Time Frame: 24-48 hours ] Hemoglobin value |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Supine vs Prone Position at Birth Before Cord Clamping A Randomized Controlled Trial | ||
| 正式标题 ICMJE | Supine vs Prone Position at Birth Before Cord Clamping A Randomized Controlled Trial | ||
| 简要概况 | This study is conducted to evaluate if the prone position of the newborn on the chest of his mother at birth before delayed cord clamping leads to better hematocrit and hemoglobin at 24-48 hours of life compared to supine position. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Randomised two arms study 盲法: Interventional 盲法描述: 主要目的: Prevention |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
210 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 1, 2020 | ||
| 预计主要完成日期 | November 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: well appearing newborn ≥ 36 weeks gestational age and born vaginally Exclusion Criteria:out born infant, infant born by caesarian section, preterm born less than 36 weeks GA, intra uterine growth restriction (IUGR: less than 10th percentile), the asphyxiated infant, infant needing immediate resuscitation, newborn with malformation (gastroschisis, omphalocele, anal atresia, severe head skin injury, congenital cardiac disease), newborn with mother with preeclampsia, gestational hypertension, diabetes, hemolytic disease, on chemotherapy, insulin or cortisone are excluded. - | ||
| 性别 |
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| 年龄 | 最小年龄：N/A ，最大年龄：2 Minutes | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Dr Brahim Bensouda，Maisonneuve-Rosemont Hospital | ||
| 研究赞助商 ICMJE | Maisonneuve-Rosemont Hospital | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Maisonneuve-Rosemont Hospital | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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