Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Weight of milk
研究概览
简要总结
Increasing evidence for an effective method of flange fitting will allow lactation consultants to better advocate for the supplies and training needed to properly fit flanges for this population, hopefully leading to increased milk output and improved experience for parents. Flanges are the part of the pump that fits over the breast and through suction, pulls on the nipple to extract the milk. Recent research showed that a new method of breast pump flange fitting, the Flange FITS TM Guide sizing method, increased milk output and improved the breast milk pumping experience for parents of healthy, term babies.
We hypothesize that the Flange FITS TM Guide sizing method will be effective in NICU parents, a population that has not been explored in current research.
We are conducting a randomized control trial to explore whether the Flange FITS process is better than the standard (manufacturers instructions) for breastpump flange fitting for new parents who are pumping their milk for their newborns in the NICU. We will randomize (1:1) participants to either the new type of flange fitting (Flange FITS) or usual standard care. The study team will assist the pumping parent participant with flange fitting according to their group. This study will ask the pumping parent participants for information about their child and their experience with pumping, and requests that they record the weight of their breast milk after each pump while in the study. The participants already have the pumps and flanges as part of their standard of care. The researchers will provide participants with a scale to weight their breastmilk after each pump while int he study. The researchers will not go into the medical record to retrieve information for the purposes of the study; all information collected for the study will come from the pumping parent participant.
详细描述
Recent research shows that a new method of breast pump flange fitting, the Flange FITS TM Guide sizing method, increased milk output and improved the breast milk pumping experience for parents of healthy, term babies. https://www.babiesincommon.com/flange-fits-guide Increasing evidence for an effective method of flange fitting will allow lactation consultants to better advocate for the supplies and training needed to properly fit flanges for this population, hopefully leading to increased milk output and improved experience for parents.
In this study we will 1:1 randomize lactating people with neonates in the NICU to the experimental group (Flange FITS Guide sizing method) or the control group (flange manufacturers sizing guide).
The investigators hypothesize that the Flange FITS TM Guide sizing method will be effective in NICU parents, a population that has not been explored in current research.
Aims:
- Determine if there is an increase in breastmilk production with pumping using the Flange FITS TM Guide sizing method.
- Determine in there is an increase in comfort with breastfeeding, breastfeeding satisfaction, length of pumping with the use of the Flange FITS TM Guide sizing method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have newborn in NICU
- •Using a breast pump Ability to pump 6-8 times a day
排除标准
- •Not using a breast pump No newborn in the NICU
研究组 & 干预措施
Control/usual care
Pumping people will be provided the usual education and flange fitting procedures.
干预措施: The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community. (Other)
Intervention group
This groups will receive the FLANGEFITS protocol.
干预措施: The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community. (Other)
结局指标
主要结局
Weight of milk
时间窗: Maximum participation is 3 weeks
The weight of the milk will be collected. A food grade scale will be used.
次要结局
- Pumping satisfaction(Maximum participation in 3 weeks.)
