Association of Temperature of Extremities and Necrotizing Enterocolitis(NEC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- necrotizing entercolitis(NEC)
研究概览
简要总结
Bloody stool and necrotizing enterocolitis(NEC) is two main focus in non-neonatal intensive care unit ward and usually lead to longed duration of hospitalization.
Neutral temperature is a environmental temperature where the infant's body temperature is normal under resting state, and the changes of body temperature and skin temperature are less than 0.2-0.3 centigrade. According the definition, a suggested temperature range is set. For example, if an infant's body weight is more than 2500 gram, the initial set of environmental temperature is 31.3 centigrade with a range of 29.8-32.8 centigrade.
low environmental temperature is a risk factor for Bloody stool and NEC. Therefore, how to set the optimal environmental temperature is a challenge.
详细描述
After birth, newborns must adapt to their relatively cold environment by the metabolic production of heat because they are not able to generate an adequate shivering response. Under the condition, environment temperature should be given to protect an infant from cold stress and cold injury, even NEC.
Therefore, the setting of the optimal environment temperature is a key focus in neonatal ward. Here, the investigators suggest a hypothesis that environment temperature should be set to keep warmth of extremities temperature and infant's body temperature is between 36.7-37.3 centigrade.
In the present study, the investigators will test the hypothesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body weight >2500 grams and/or gestational age >35 weeks
- •an infant is diagnosed with hyperbilirubinemia and/or pneumonia without need for oxygen inhalation
排除标准
- •congenital deformities
- •refusal of parents' consent
结局指标
主要结局
necrotizing entercolitis(NEC)
时间窗: before discharge
a infant is suffered from NEC
bloody stool
时间窗: before discharge
a infant is suffered from bloody stool
次要结局
- late-onset sepsis(LOS)(before discharge)
研究者
Chen Long,MD
director
Children's Hospital of Chongqing Medical University