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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05297799
• Other study ID #: HGP2022
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: September 2023

Study information

• Verified date: January 2023
• Source: Ameda, Inc.
• Contact: Susan M Shondel, MD
• Phone: 330-571-9889
• Email: shondels[@]summahealth.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Breast Pumping

Intervention

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.

Locations

Country	Name	City	State
United States	Summa Health	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ameda, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	milk volume	milk volume pumped during multiple sessions over a 24-hour period	At day 14