Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Gastric residual volume in mililitres after every feeding
研究概览
简要总结
Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist for the optimal milk temperature for preterm infants. Therefore, in this study the investigators aimed to examine the effects of feeding temperature and the possible morbidities.
详细描述
Feeding intolerance is one of the most frequent problems among preterm infants. These infants are fed with expressed breast milk or preterm formulas of which the temperature is not routinely measured. In this study, the investigators aimed to examine the effects of feeds with warm versus room temperature milk in preterm infants. Infants with a birth weight of ≤1500 g or gestational age of ≤ 34 weeks were included in the study and assigned to two different feeding temperature groups (22-24°C and 32-34°C). Some infants in both groups were exclusive breast milk fed and some received artificial milk. Feeding tolerance of patients in both groups and the consequences were evaluated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The infants were randomly assigned using the last digit of their hospital identification number to two different groups with different feeding temperatures. Only the nurse giving the primary care was not blinded.
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born to birth weight of ≤1500 g
- •Infants born to gestational age of ≤ 34 weeks
排除标准
- •Genetic syndrome
- •Gastrointestinal system anomalies
- •Patients born small for their gestational age
研究组 & 干预措施
Room temperature
All of the infants in neonatal intensive care units are used to be fed with milk at 22-24°C which is close to room temperature.
干预措施: Room temperature (Other)
Warmer temperature
The investigators decided to feed the infants in this group with warmer milk at to examine the effects of feeding temperature.
干预措施: Warmer temperature (Other)
结局指标
主要结局
Gastric residual volume in mililitres after every feeding
时间窗: through study completion, an average of 6 months
Gastric residual volume amount during the study
次要结局
- Body weight at discharge(through study completion, an average of 6 months)
- Transition time to total enteral feeding(through study completion, an average of 6 months)
- Need for anti reflux treatment(through study completion, an average of 6 months)
- Daily weight gain(through study completion, an average of 6 months)
研究者
Ozge Altun Koroglu
Associated Professor, M.D.
Ege University