Status:
UNKNOWN
Clinical Validation of the Ameda Pearl - An Electric, Hospital Grade, Multi-User Breast Pump
Lead Sponsor:
Ameda, Inc.
Conditions:
Breast Pumping
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study introduces a new Ameda electric multi-user, hospital-grade breast pump, the Ameda Pearl, to mothers who choose to exclusively breast pump until their infants are able to breastfeed.
Detailed Description
The purpose of this study is to determine whether exclusively pumping mothers of hospitalized infants greater than or equal to 28 weeks gestational age can come to volume, defined as a minimum of 500m...
Eligibility Criteria
Inclusion
- Delivered an infant \>28 weeks gestational age
- Infant is unlikely to be developmentally ready to breastfeed until \>2 weeks old
- Wish to initiate lactation and express breast milk for at least two weeks, exclusively using the study pump
- Started or plan to start pumping within six hours of delivery
- Agree to double pump with study pump to express breast milk at least 8 times per 24 hours for a minimum of 15 minutes each session during the study participation period
- Read and understand the English language
- Adults, over or equal to the age of 18 are being recruited in this study so consent can be given by the participant directly. These potential participants could be included in the study if their infants were born in the third trimester, greater than or equal to 28 weeks gestational age, and were unable to breastfeed due to prematurity, developmental stage and/or physical anomalies preventing their ability to breastfeed directly at the breast.
Exclusion
- Have had breast reduction surgery
- Have a history of low milk production
- Have any medical or physical condition that in the opinion of the investigator would prevent them from participating in the study
- Are currently breastfeeding another child
- Fail the initial Investigator Breast Tissue Assessment (Attachment #4)
- Have begun breast pumping with another breast pump to express breast milk
- Are taking any medications or supplements that are meant to alter milk supply volume
Key Trial Info
Start Date :
July 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05297799
Start Date
July 21 2022
End Date
September 1 2023
Last Update
January 20 2023
Active Locations (1)
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1
Summa Health
Akron, Ohio, United States, 44304