Clinical Validation of the Ameda Pearl - An Electric, Hospital Grade, Multi-User Breast Pump
Status unconfirmed · Not applicable
Conditions studied: Breast Pumping
In brief
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.
Key facts
- Study ID
- NCT05297799
- Run by
- Ameda, Inc.
- People needed
- 35
- Starts
- 2022-07-21
- Expected to finish
- 2023-09-01
- Last updated by the study team
- 2023-01-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Summa Health — Akron, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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