NCT05297799

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

Clinical Validation of the Ameda Pearl Breast Pump

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Ameda, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Breast Pumping

Interventions

Type	Name	Description
DEVICE	Ameda Pearl breast pump	The Ameda Pearl breast pump is a powered, multi-user breast pump with stimulation and expression modes and independently user-selectable speed and suction control in each mode.

Timeline

• Start date: 2022-07-21
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-03-28
• Last updated: 2023-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study