Effects of Swaddling During Bottle Feeding on Infants Born Preterm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Swallow coordination measured by subtest of Early Feeding Skills Assessment (EFS)
研究概览
简要总结
The purpose of this randomized, within-subject, cross-over study is to examine if swaddling affects bottle feeding performance in infants born preterm. Results from research will have implication on neurobehavioral and physiologic outcomes as important indicators for the possible effect of swaddling during bottle feeding.
详细描述
Once an infant is orally feeding a minimum of two times per nursing shift for four consecutive nursing shifts, the infant will be randomly assigned to receive the intervention (swaddling) or control condition (no swaddling) first, by the research OT randomly choosing an envelope with the assignment enclosed. The intervention and control feedings for each infant will be consecutive and will take place at the infant's bedside in the NICU. Infants will be assessed at each nursing care time for feeding readiness by the research OT and feeding OT according the policies of the NYU Langone Medical Center NICU, which utilizes the Infant-Driven Feeding Scale-Readiness (Appendix B) (Ludwig & Waitzman, 2006). When the infant demonstrates readiness, the first condition will be initiated. At the next feeding when the infant demonstrates readiness, the opposite condition will be applied. If the infant is not available due to procedures or not demonstrating feeding readiness, at the next two caregiving times after the first feeding, the infant will be discontinued for that day and will start the study over the next day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all infants born before 34 weeks gestational age will be included as long as they do not have any exclusion criteria
- •infants born before 34 weeks gestational age is 33 weeks 3 days to 35 weeks 0 days, with attainment of exclusive bottle feeding at 36 weeks gestational age at the earliest.
- •Infants who are multiples will be included but restricted to twins and triplets.
- •Infants will only be included if their parents provide informed consent for participation of their infant in the study.
排除标准
- •The exclusion criteria are factors commonly associated with feeding problems in infants beyond prematurity, including:
- •Infants who are exclusively breastfed
- •Higher order multiples than twins and triplets (ie. quadruplets)
- •Infants with conditions that may affect feeding performance:
- •Grades III and IV intraventricular hemorrhage
- •Necrotizing enterocolitis
- •Congenital cardiac anomalies (except medically managed patent ductus arteriosus)
- •Genetic syndromes
- •Craniofacial abnormalities
结局指标
主要结局
Swallow coordination measured by subtest of Early Feeding Skills Assessment (EFS)
时间窗: 1 Day
Physiologic stability measured by subtest of Early Feeding Skills Assessment (EFS)
时间窗: 1 Day
Stability of heart rate and respiratory rate are indicative of the ability of the infant born preterm to cope with stress during bottle feeding
Feeding recovery measured by subtest of Early Feeding Skills Assessment (EFS)
时间窗: 1 Day
Number of significant oxygen desaturations
时间窗: 1 Day
Oral feeding readiness measured by subtest of Early Feeding Skills Assessment (EFS)
时间窗: 1 Day
Number of significant changes in heart rate (bradycardia
时间窗: 1 Day
Oral motor organization measured by subtest of Early Feeding Skills Assessment (EFS)
时间窗: 1 Day
Feeding engagement measured by subtest of Early Feeding Skills Assessment (EFS)
时间窗: 1 Day
次要结局
未报告次要终点