The Effect of Early Skin Contact Combined With Breastfeeding on Oral Feeding in Premature Infants ≤30 Weeks of Gestation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Transition time from the initiation oral feeding to full oral feeding
研究概览
简要总结
Skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants
详细描述
This study is conducted at the level 3 NICU of the Children's Hospital of Fudan University, Shanghai, People's Republic of China, a tertiary medical center. Infants admitted to the NICU are all outborn infants.
The study is approved by the Ethics Committee of the Children's Hospital of Fudan University. Signed parental consent is obtained before participants'entry into the study. The RCT is conducted to evaluate the effectiveness of skin-to-skin combined with breastfeeding reduce the transition time from tube feeding to independent oral feeding.
The recruited infants are assigned to intervention group and control group.
Data are presented as means ± sds for continuous variables with normal distribution and percentages (%) for categorical variables. One-way analysis of variance and Fisher exact test is used to compare infants' baseline characteristics among the two groups. All statistical analyses are conducted using SPSS. A p value of less than 0.05 is regarded as statistically significant.
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
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age ≤30 weeks
- •birth weight < 1500g
- •age of admission <72 hours
- •no congenital malformation
排除标准
- •mother has trouble in communicating
结局指标
主要结局
Transition time from the initiation oral feeding to full oral feeding
时间窗: During the procedure
Transition time was defined as the days needed from introduction of oral feeding to obtain autonomous oral feeding when the nasogastric tube was removed and all the daily milk volume was taken from the bottle.
次要结局
- Exclusive breastfeeding at discharge(During the hospitalization, an average of 2 to 3 months)