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临床试验/CTRI/2021/05/033670
CTRI/2021/05/033670已完成1 期

Quality improvement measures in reducing hypothermia among at-risk neonates

Dr Soham Kulkarni1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年5月25日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Percentage of improvement in thermoregulation after QI.

研究概览

简要总结

Phase I-

Axillary temperature using digital thermometer of

  1. All VLBW babies delivered at Kasturba hospital will be measured after resuscitation and at admission to NICU.

  2. All babies going for surgery to OT before leaving and at arrival to NICU

  3. All babies going for investigations (CT,MRI) before leaving and at arrival to NICU.

Incidence of hypothermia will be noted.

Phase II-

Hypothermia prevention team (myself along with nursing staff and neonatology staff representatives ) will optimise the NICU policy for neonatal transport with inputs from OBGY, Anaesthesia and radiology staff.

  1. Knowledge of health care providers pre quality improvement will be tested by questionnaire

  2. Quality improvement bundle will be developed based on phase I data analysis.

  3. Quality improvement bundle will include use of plastic wraps, exothermic blankets, caps, socks and gloves wherever applicable and any other measures based on phase I data.

  4. Quality improvement bundle and feasibility of thermoregulatory equipment will be based on neonatal needs

Phase III-

  1. Knowledge of health care providers post quality improvement will be tested by questionnaire

  2. Axillary temperatures will be measured by digital thermometers after implementation of new initiatives

The results will then be compared with pre quality improvement values.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
0.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • All neonates delivered at Kasturba hospital, Manipal with gestational age less than 32 weeks or birth weight less than 1500 g and admitted to NICU
  • Neonates transported to Operating Rooms for surgical intervention
  • Neonates requiring intra hospital transport for imaging studies.

排除标准

  • Neonates less than 24 weeks of gestation
  • Neonates less than 500 g birth weight
  • Neonates with major congenital malformations.

结局指标

主要结局

Percentage of improvement in thermoregulation after QI.

时间窗: Phase I- May 2021-September 2021 | Phase II- October 2021- February 2022 | Phase III- March 2022- August 2022

次要结局

  • Reduction in percentage of mortality and morbidity associated with hypothermia.(Phase I- May 2021-September 2021)

研究者

发起方
Dr Soham Kulkarni
申办方类型
Other [self]

研究点 (1)

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