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临床试验/NCT01671241
NCT01671241Unknown3 期

Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping

University of Padova2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
80
试验地点
2
主要终点
Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later

研究概览

简要总结

Hypothermia after delivery is a world-wide problem associated with morbidity and mortality. The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very preterm babies and represents the standard of care recommended by the International Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the proportions of hypothermic infants at NICU admission (temperature <34°C) in the wrapped group (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The combination of body and head protection with a polyethylene wrap needs to be evaluated further. The investigators conducted a prospective, randomized, controlled trial in very preterm infants to evaluate whether a polyethylene total body wrapping (body plus head) prevents heat loss after delivery better than polyethylene occlusive wrapping.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Minute 至 3 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants <29 weeks' gestation born in the study centers

排除标准

  • Congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team

结局指标

主要结局

Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later

次要结局

  • Mortality prior to hospital discharge
  • Major brain injury
  • percentages of hyperthermic infants at NICU admission

研究者

发起方
University of Padova
申办方类型
Other
责任方
Sponsor

研究点 (2)

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