The Effects of Mother-infant Skin-to-skin Contact on Cumulative Stress of Preterm Infants in the Neonatal Intensive Care Unit : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Changes on the concentration of cortisol of preterm infants
研究概览
简要总结
This study will evaluate the effect of maternal-infant skin-to-skin contact (SSC) versus routine care on general stress in preterm infants in the neonatal intensive care unit (NICU).
详细描述
Primary outcome of this trial to investigate the effects daily skin-to-skin contact on cumulative stress through measures salivary cortisol. The intervention group will receive mother-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge. The control group will receive routine neonatal care during hospitalization except skin-to-skin contact. The concentration of salivary cortisol and other infant and parental outcomes will be measured in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 0 Hours 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •31 weeks≤gestational age<37 weeks;
- •Birth weight ≥ 1500g;
- •Admission age < 24h;
- •No congenital malformations;
- •Vital signs are stable and does not use ventilator and other auxiliary life support systems.
排除标准
- •Severe periventricular / intraventricular hemorrhage (grade III);
- •Receiving sedation or vasopressor or analgesics opiodis and corticosteroids;
- •Mother unable to communicate and communicate normally; Mother has a history of depression.
结局指标
主要结局
Changes on the concentration of cortisol of preterm infants
时间窗: From 3 days of life (baseline) to 7 days of life
At 3 days of life (baseline) and 7 days of life, the saliva sample will collected from preterm infants by a neonatal nurse. The concentration of salivary cortisol will be measured using by radioimmunoassay.
次要结局
- Crying time(At the preterm infants 7 days of life)
- Length of hospital stays(Through study completion, an average of 40 days)
- Changes on the level of cortisol during heel lancet(At the preterm infants 7 days of life)
- Score of Edinburgh Postnatal Depression Scale(Through study completion, an average of 40 days)