Ignite Creation Date:
2024-05-06 @ 1:12 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03960190
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2019-05-15
Brief Title:
Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant
Sponsor:
Philips Consumer Lifestyle
Organization:
Philips Consumer Lifestyle
Study Overview
Official Title:
Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EUREKA
Brief Summary:
Babies are the best in class in order to get human milk out of a lactating breast With this in mind Philips has developed the a new electric breast pump attempting to mimic the babies sucking behavior The new electric breast pump includes a new vacuum profile and 2 new expression kits
Detailed Description:
Breast pumps currently on the market function by applying vacuum directly to the breast The effect of a build-up of pressure within the breast due to the accumulation of milk combined with the external negative pressure introduced by the breast pump results in the expression of milk However in order to express sufficient amounts of milk it is important to stimulate the Milk Ejection Reflex MER The MER also called letdown draught ejection expulsion or pumping reflex is described as a response of the mammary gland to oxytocin When the nipple is stimulated the mothers posterior pituitary gland releases oxytocin into the bloodstream Upon reaching the breast tissue oxytocin provokes contraction of cells within the structure of the breast causing milk flow Without the MER successful breastfeeding or breast milk expression cannot happen In order to stimulate the MER Philips has developed 2 new expression kits to better mimic the suckling pattern of an infant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None