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Clinical Validation of the Ameda Pearl - An Electric, Hospital Grade, Multi-User Breast Pump

Breast Pumping Clinical Trial

Official title:
Clinical Validation of the Ameda Pearl Breast Pump

Clinical Trial 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.

Clinical Trial 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 500ml/24 hours, while using the Ameda Pearl breast pump during the first 14 days postpartum. The Ameda Pearl has a stimulation and expression mode, as well as separate speed (30-120 cycles per minute) and suction (-30 to -250 mmHg) push-button controls that are adjustable in each mode. Study data will include daily milk volumes, suction pressures, pumping times, ending speeds and comfort by mothers of preterm infants to determine if the pump facilitates achievement of 'coming to volume' status. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05297799
Study type Interventional
Source Ameda, Inc.
Contact Susan M Shondel, MD
Phone 330-571-9889
Email shondels@summahealth.org
Status Recruiting
Phase N/A
Start date July 21, 2022
Completion date September 2023
View Details
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