Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)
A video of the delivery room management will be taken using standardized conditions. The video will be evaluated either locally by those directly involved in the delivery room care of this specific infant or anonymously at the main study center. Using a standardized evaluation form a set of predefined interventions is rated regarding at what time they took place and at what time they should have taken place. The difference in time for all interventions is summed up to a score. This score should allow to assess the delivery room management in comparison to the desired standard as well as between hospitals. The evaluation forms of all centers will be analyzed at the main study center to define correlations between certain delivery room interventions and short term outcome.
Aim of the study is to
- gather data on how delivery room care is currently done,
- come closer to an agreement between different NICUs towards what should be done in the delivery room under what circumstances in which way,
- find those interventions with potential influence on short term outcome. Those aspects of management that are different between centers and show correlation with short term outcome will be the focus of future prospective intervention trials in order to find the best way how to take care of preterm infants in the delivery room.
Hypothesis:
In preterm infants <32;0 weeks of gestational age a correlation exists between specific delivery room interventions and short term outcome.
研究概览
地位
条件
详细说明
Delivery room interventions measured are: Stimulation, Ventilation, Oxygen, Cardiac massage, Suctioning, ven / art access, fluid and drugs given
Short term outcome measurements are: IVH, PVL, Pneumothorax, BPD, DOL when first time 120mL/kg oral feeds, NEC, ROP, death, Head circumference at discharge
研究类型
注册 (预期的)
联系人和位置
学习地点
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Greifswald、德国、17475
- 招聘中
- University Children's Hospital
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接触：
- Helmut Küster, MD
- 电话号码：-49-3834-86-22476
- 邮箱：kuester@uni-greifswald.de
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- preterm infants <32;0 weeks of gestational age
Exclusion Criteria:
- Infants in whom no life support is being planned - e.g. those with lethal malformations
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The Delivery Room Management Score (DRMS) negatively correlates with short term outcome (none of (death, IVH °3 or 4, PVL, pneumothorax, BPD, NEC °2 or 3, ROP °3 to 5))
大体时间：Outcome is measured at first discharge from your hospital
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On special request by the PRS-Team: this is any time between 1 Minute of life in case of delivery room death and up to 2 and more years in case of several complications during the hospital stay.
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Outcome is measured at first discharge from your hospital
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合作者和调查者
调查人员
- 首席研究员：Helmut Küster, MD、University Children's Hospital of Greifswald, Germany
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.