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临床试验/NCT05234151
NCT05234151Unknown不适用

The Newborn Early Warning Score: Een Mixed Method Onderzoek

PXL University College1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年9月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1
试验地点
1
主要终点
NEWS

研究概览

简要总结

Maternity wards record daily observations such as temperature, color, urine, faeces and weight of the newborn in the baby file. There is no structure and no uniformity in recording and interpreting them and in time to notify the doctor.

Adults who become ill, have clearly observable and interpretable signs such as fever, changed heart rate, and increasing pain symptoms. Verbal communication also contributes to timely risk assessment. In newborns, this is absent and vital parameters often remain good for some time despite deterioration in health status. Changes in behavior, micturition and weight can be a sign of infection or cardiopathy. Scientific studies show that in adults and children, signs of deterioration in health status are often not recognized and not acted immediately. (Paliwoda et al., 2016)

Early Warning Score Systems are used in several hospital settings with good results. ( Jensen et al., 2017; Alam et al., 2014) However, there is no universal scale that can be used for the entire hospital population. In newborns up to 120 hours postpartum, vital parameters such as heart rate, blood pressure, and saturation are currently not part of daily monitoring unlike in other hospital populations. Physical parameters such as color, micturation, weight and behavior can be a sign of decompensation and are not included in already existing measurement tools.

The healthcare industry has been very standardizing in recent years, which increases the need for a scientifically based tools tailored to the newborn.

详细描述

Problem Statement. Maternity wards record daily observations such as temperature, color, urine, stool and weight of the à terme newborn in the baby file. There is no structure and no uniformity in recording and interpreting these observations, nor in when the doctor should be notified.

In adults who become ill, there are clearly observable and interpretable signs such as fever, changed heart rate, and increasing pain symptoms. Verbal communication also contributes to timely risk assessment. In newborns, this is absent and vital parameters often remain good for some time despite deterioration in health status. Changes in behavior, micturition and weight can be a sign of infection or cardiopathy. Scientific studies show that in adults and children, signs of deterioration in health status are often not recognized and not acted upon in a timely manner. (Paliwoda et al., 2016) Early Warning Score Systems are used in several hospital settings with good results. ( Jensen et al., 2017; Alam et al., 2014) However, there is no universal scale that can be used for the entire hospital population. In à terme newborns up to 120 hours postpartum, vital parameters such as heart rate, blood pressure, and saturation are currently not part of daily monitoring unlike in other hospital populations. Physical parameters such as color, micturation, weight and behavior can be a sign of decompensation and are not included in already existing measurement tools.

The healthcare industry has been very standardizing in recent years, which increases the need for a scientifically based tool tailored to the newborn.

Methodology. In a first phase, a literature review will be performed to find out which parameters and trigger scores are essential in the early detection of problems in newborns up to 120 hours postpartum. A scientifically based tool will be developed to be tested, adjusted and validated in two Limburg maternities. In a before and after measurement, 20 midwives will be interviewed via semi-structured interviews about their findings before and after the use of the tool. From the medical records, information such as parameters, warning signals and time indicators will be collected and compared.

Expected Results. The research will result in descriptive statistics on the one hand, the feedback of info from the records and on the other hand from the qualitative analysis of the feedback from the interviews.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • newborn in the maternity ward

排除标准

  • premature baby's
  • ill baby's

结局指标

主要结局

NEWS

时间窗: 2 years

Newborn Early Warning Score

次要结局

未报告次要终点

研究者

发起方
PXL University College
申办方类型
Other
责任方
Sponsor

研究点 (1)

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