Effect of Non-nutritive Sucking on the Breast to Enhance Breastfeeding in Infants Who Are Born Prematurely
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Number of days to transition from full tube to full oral feeds
研究概览
简要总结
The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will lead to more success with direct breastfeeding than non-nutritive sucking on a pacifier in preterm infants.
详细描述
Breast milk is vital in the nourishment of premature infants. Early interventions which focus on enhancing infants' oral motor skills required for breastfeeding are needed. There is very limited evidence on early interventions aimed at maintaining rudimentary sucking skills needed for breastfeeding in this high risk population. The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will enhance breast feeding performance in preterm infants.
The target population will consist of clinically stable preterm infants born less born less than or equal to 34 weeks gestational age and whose mother's intention are to breastfeed. Infants will be randomized into the non-nutritive sucking on emptied breast or pacifier group. Both interventions will be administered by mothers. Time to transition to full oral feeding, breastfeeding acquisition at hospital discharge and breastfeeding duration at six months of age will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor, responsible for data collection and follow up interview post hospitalization, is blind to group assignment.
入排标准
- 年龄范围
- — 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born less than or equal to 34 weeks gestational age (GA);
- •appropriate size for their GA;
- •receiving nasal continuous positive airway pressure;
- •receiving only enteral feedings (orogastric or nasogastric);
- •mothers are pumping their milk.
排除标准
- •congenital anomalies
- •mother not expressing milk
- •transferred in hospital
结局指标
主要结局
Number of days to transition from full tube to full oral feeds
时间窗: Through study completion, an average of 2 years
Number of days to transition from full tube to full oral (bottle/breast) feedings
次要结局
- Breastfeeding acquisition at hospital discharge(Through study completion, an average of 2 years)
- Breastfeeding duration(Through study completion, an average of 2 years)
研究者
Dr. Sandra Fucile
Assistant Professor-adjunct
Queen's University