跳至主要内容
临床试验/NCT00603837
NCT00603837已完成不适用

Thermal Defense of Extremely Low Gestational Age Newborns (ELGANs) During Resuscitation: Exothermic Mattresses vs. Polyethylene Wrap

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Neonatal Intensive Care Unit (NICU) Admission Temperature

研究概览

简要总结

Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming blankets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
24 Weeks 至 28 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Participants in this study will be selected from the inborn population at University Hospital. Eligible patients will be selected from the group of babies with estimated gestational ages of 24-28 weeks and <1250g.

排除标准

  • Congenital anomalies with open lesions such as meningomyelocele, or omphaloceles
  • Blistering skin conditions
  • Resuscitation not performed secondary to infant being below limits of viability as assessed by the in-house attending physician (specifically, according to current NRP recommendations):
  • Where gestation, birth weight, and/or congenital anomalies are associated with almost certain early death, and unacceptably high morbidity is likely among the rare survivors, resuscitation is not indicated. Exceptions may be made based on parental desires.
  • Newborns with confirmed gestation age of less than 24 weeks or birth weight less than 400 grams
  • Anencephaly
  • Confirmed Trisomy 13 or Trisomy 18 syndrome
  • Meconium staining of amniotic fluid
  • Birth assessment of gestational age > 28 weeks or >1250 grams
  • Maternal temp >38 degrees C around the time of delivery.

结局指标

主要结局

Neonatal Intensive Care Unit (NICU) Admission Temperature

时间窗: At time of admission to the NICU - usually within 10-15 min of birth

Axillary temperature of the infant upon arrival to the neonatal intensive care unit.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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