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临床试验/NCT02769468
NCT02769468已完成不适用

Effect of Temperature Probe Placement in Delivery Room on Temperature at the Admission in the Neonatal Intensive Care Unit (NICU) of Premature Infants?

Maisonneuve-Rosemont Hospital2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2015年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
2
主要终点
The average temperature right axillary.

研究概览

简要总结

The aim of the study is to compare the effect of 3 different skin temperature placement probe in the case room on the admission temperature to the NICU in preterm infants. The authors aim to evaluate which placement results in more preterm in the acceptable range (36.5-37 °C).

详细描述

It's a prospective randomized trial conducted at Maisonneuve Rosemont Hospital, neonatal tertiary center located in Montreal with over 2600 annual deliveries. All pregnant women who are expecting to deliver a preterm infant with gestational between 28 and 35 6/7 weeks will be eligible to be enrolled into the study and informed consent is obtained.

Simple randomization is accomplished by opening a sealed pre-set envelope with group assignment before delivery.

Group 1: The probe is placed lateral from the spine, 1 cm above the intergluteal cleft, and in side position to the flank between the hips and the ribs.

Group 2: The probe is placed on the chest, 1 cm above the left nipple. Group 3: The probe is placed deep in the left axilla

At birth, all the preterm are immediately placed under a radiant warmer and resuscitated as per Neonatal resuscitation program (NRP) guidelines. Application of a skin temperature probe set at 36.5°C, for servo-controlled thermoregulation by 2 minutes of life. Probes will be fixed with an insulated reflective water-soluble gel probe.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
28 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

The Back

Active Comparator

The probe is placed lateral from the spine, 1 cm above the intergluteal cleft, and in side position to the flank between the hips and the ribs.

干预措施: The Back (Other)

Chest

Active Comparator

The probe is placed on the chest, 1 cm above the left nipple.

干预措施: Chest (Other)

Left Axilla

Active Comparator

The probe is placed deep in the left axilla

干预措施: Left Axilla (Other)

结局指标

主要结局

The average temperature right axillary.

时间窗: 1 year

The average temperature axillary at the admission in 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
责任方
Principal Investigator
主要研究者

Dr Brahim Bensouda

MD. Assistant Professor

Maisonneuve-Rosemont Hospital

研究点 (2)

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