Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT07268105
Brief Summary:
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.
Detailed Description:
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).
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.
Aims:
1. Determine if there is an increase in breastmilk production with pumping using the Flange FITS TM Guide sizing method.
2. 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.
Study:
NCT07268105
Study Brief:
Protocol Section:
NCT07268105