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临床试验/CTRI/2019/12/022475
CTRI/2019/12/022475Other3 期

A prospective open label randomised controlled trial to evaluate the contribution and usefulness of test device (Temp watch) in management of hypothermia in Low Birth Weight (LBW) infants in India.

Bempu Health Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
Other
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1.LBW infants ( <2,200g) without congenital anomalies discharged from hospital.
  • 1.parents willing to give written informed consent
  • 2.Families residing within 50 km from the hospital (or a distance that is contextually reasonable for a member of the study team to travel to each infantâ??s home once per week).
  • 3.Baby is able to maintain temperature without radiant warmers
  • 4.Baby is haemo-dynamically stable (normal CFT, strong peripheral pulses)
  • 5.Baby accepting breast feeds well
  • 6.Primary illness has resolved
  • 7.Mother should be confident of taking care of the baby at home
  • 8.Parent are reachable on mobile

排除标准

  • 1.infants allergic to Investigational Medical Device.
  • 2.Infants readmitted to NICU for serious illness.
  • 3.New-born is not clinically stable
  • 4.Baby is discharged with a condition known to impact its ability to gain weight, such as downâ??s syndrome, metabolic or genetic disorders
  • 5.New-borns being referred to higher centers
  • 6.Contact details of parents are not available

研究者

发起方
Bempu Health Pvt Ltd

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