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

Clinical Validation of the Ameda Pearl Breast Pump

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Pumping
• Intervention / Treatment: Device: Ameda Pearl breast pump

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.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan M Shondel, MD; Phone Number: 330-571-9889; Email: shondels@summahealth.org

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44304
      • Recruiting
      • Summa Health
      • Contact: Susan M Shondel, MD; Phone Number: 330-571-9889; Email: shondels@summahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactating women; New mothers whose infants born after 28 weeks gestational age are unable to breastfeed will exclusively breast pump their breast milk with an Ameda Pearl breast pump for a minimum of the first 14 days postpartum.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
milk volume	milk volume pumped during multiple sessions over a 24-hour period	At day 14

Collaborators and Investigators

• Sponsor: Ameda, Inc.
• Investigators: Principal Investigator: Susan M Shondel, MD, Summa Health

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 26, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HGP2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No