Randomized Crossover Trial of the Nifty Feeding Cup and a Medicine Cup in Preterm Infants Who Have Difficulty Breastfeeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Caregiver Satisfaction [Immediate]
研究概览
简要总结
The investigators will establish an evidence base for the Nifty Feeding Cup by evaluating its effectiveness and caregiver satisfaction. The investigators will conduct a randomized crossover trial that compares the Nifty Feeding Cup to a standardized, generic medicine cup used to feed preterm infants with breastfeeding difficulties at Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana.
详细描述
The investigators aim to compare the Nifty Feeding Cup to a standardized, generic cup in up to 200 preterm infants. The aim and hypotheses were selected based on the most informative outcomes given the scope of the funding. The investigators will test the hypotheses that Nifty Feeding Cup feeding compared to generic cup feeding will result in:
- Less spillage
- Greater caregiver satisfaction
- Shorter duration of feeds
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born preterm (<37 weeks gestational age) at time of birth
- •Corrected gestational age is <37 weeks per the modified Dubowitz score on date of enrollment
- •Diagnosed with feeding difficulties
- •Patient in the mother-baby unit at KATH
- •Clinically indicated to start cup feeding (including an infant who has a nasogastric tube and is cup feeding or indicated to start cup feeding)
- •Has an anticipated hospital stay that is at least 48 hours
- •At least 18 years of age
- •One of the following biologic family members of the infant (Mother, Grandmother, Aunt)
- •Self-identifies as the primary feeder of the infant
- •Prior experience feeding the potential infant participant with nipple feeding (e.g. breast feeding, bottle feeding) or nasogastric [NG] tube
- •Verifies willingness to comply with all study procedures
排除标准
- •Congenital anomaly except for minor anomalies (e.g. an extra digit or ear tag is okay)
- •Other condition or situation that makes infant unlikely to be able to comply with study procedures. Examples include the infant anticipated to not be in hospital long enough, infant has a suspected intestinal obstruction, or necrotizing enterocolitis.
- •No mother, grandmother, or aunt caregiver available to participate in study
- •Enrolled in another study at KATH that would interfere with his/her ability to participate in this study.
研究组 & 干预措施
NIFTY Feeding Cup First
Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.
干预措施: Nifty feeding cup (Other)
NIFTY Feeding Cup First
Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.
干预措施: Generic medicine cup (Other)
Generic Medicine Cup First
Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.
干预措施: Nifty feeding cup (Other)
Generic Medicine Cup First
Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.
干预措施: Generic medicine cup (Other)
结局指标
主要结局
Caregiver Satisfaction [Immediate]
时间窗: 24-36 hours
Caregiver's satisfaction will be the cup she prefers, which will be recorded in the In-Hospital Preference Survey completed after the caregiver has finished the feeding portion of the study. Data refers to number of caregivers who prefer the Nifty Cup.
Spillage
时间窗: 24-36 hours
Spillage will be reported as a percent with the amount of milk in grams spilled/mopped up divided by the total amount of milk weighed in grams less the total amount of milk not used. Each caregiver-infant pair will be provided with a bib cloth for each observed feeding. The bib cloth will be weighed before and after each feed and the weights recorded on the Feeding Assessment form. The difference between the pre and post weights will be used as the measure of the amount spilled. A digital scale will be used to measure the milk weight, which will be recorded in grams.
次要结局
未报告次要终点