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

NCT05297799 | Unknown FDA Device

• 1 other identifier: HGP2022
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Pumping

Outcome Measures

Primary Outcomes (1)

• milk volume

  milk volume pumped during multiple sessions over a 24-hour period

  At day 14

Study Arms (1)

Lactating women

EXPERIMENTAL

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

Interventions

Ameda Pearl breast pump DEVICE

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.

Lactating women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ameda, Inc.: lead

Study Sites (1)

Summa Health

Akron, Ohio, 44304, United States

RECRUITING

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Susan M Shondel, MD

  Summa Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan M Shondel, MD

CONTACT

330-571-9889; shondels@summahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Lactating women

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 28, 2022
• Study Start: July 21, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)