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临床试验/CTRI/2019/10/021577
CTRI/2019/10/021577尚未招募不适用

Comparison of Pediatric Early Warning Scores in Malnourished Children in Emergency A prospective observational study

PGIMER1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
PGIMER
入组人数
500
试验地点
1
主要终点
To evaluate different padiatric early warning scores in malnourished patients in predicting mortality and clinical deterioration

研究概览

简要总结

The study will be conducted at Emergency Room, Dept. of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research, Chandigarh.Sample Size:

All malnourished patients presenting to Advanced Paediatric Centre Emergency Room

Inclusion Criteria: All malnourished children presenting to emergency room of PGIMER; Age > 1 month to <12 years

Exclusion criteria: Malnourished children brought to ER in cardiopulmonary arrest or died within one hour of presenting.

Children admitted in ER, meeting the malnutrition criteria will be selected by a using a Case Screening Performa on day 1 of their admission . Enrolment will be done only after obtaining written informed consent

Pews Scores to be tested:

  1. Brighton PEWS (Monaghan)

  2. Bedside PEWS(Parshuram et al)

  3. Cardiff and Vale PEWS(Edwards et al)

  4. C CHEWS PEWS(McLellan et al)

  5. Birmingham and Toronto PEWS(Duncan et al)

Data collection:

Various clinical parameters will be assessed as per the different paediatric early warning scores at different intervals from admission to outcome ..

Time point of data collection:

At admission followed by 6 hourly intervals for 24 hours and 8 hourly thereafter i.e. admission ,6 hours, 12 hours, 18 hours, 24 hours, 32 hours, 40 hours, 48 hours or till mortality or clinical deterioration (defined as need for intubation, shift to picu, need for inotropes or cardiopulmonary arrest)occurs(within 48 hours).

PEWS Documentation:

Clinical parameters are documented by residents posted in the emergency room in monitoring charts used in APC, PGIMER. The PEWS score will be calculated and documented based on these records

Numeric score will be calculated for the different scoring systems. A PEW score will be calculated for each interval during the defined 48 hour period. The validity and comparison of the PEWS will be expressed by the areas under the receiver operating characteristic (ROC) curves, sensitivity and specificity ,positive likelihood ratios and negative likelihood ratios . ROC analysis will be performed to study the ability of various scores to predict clinical deterioration. The area under curve (AUC) will be used as a measure of overall performance of ROC curve , in this case, the ability of each score to predict clinical deterioration or mortality of the malnourished child

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • All malnourished children presenting to emergency room of APC PGIMER Age > 1 month to <12 years.

排除标准

  • Malnourished children brought to ER in cardiopulmonary arrest or died within one hour of presenting.

结局指标

主要结局

To evaluate different padiatric early warning scores in malnourished patients in predicting mortality and clinical deterioration

时间窗: ,6 hours, 12 hours, 18 hours, 24 hours, 32 hours, 40 hours, 48 hours or till mortality or clinical deterioration occurs(within 48 hours)

次要结局

  • To compare different PEWS in different age groups as an indicator to predict mortality and clinical deterioration.(,6 hours, 12 hours, 18 hours, 24 hours, 32 hours, 40 hours, 48 hours or till mortality or clinical deterioration occurs(within 48 hours))

研究者

发起方
PGIMER
申办方类型
Research institution and hospital

研究点 (1)

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