Clinical Validation of the Ameda Pearl - An Electric, Hos... | NCT05297799

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

NCT05297799

Sponsor

Ameda, Inc.

Status

Unknown status

Last Update Posted

Jan 20, 2023Actual

Enrollment

35Estimated

Phase

Not Applicable

Conditions

Breast Pumping

Interventions

Ameda Pearl breast pump

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2022Actual

Primary Completion Date

Sep 2023Estimated

Completion Date

Sep 2023Estimated

First Submitted Date

Feb 26, 2022

First Submission Date that Met QC Criteria

Mar 24, 2022

First Posted Date

Mar 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2023

Last Update Posted Date

Jan 20, 2023Actual

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001942	Breast Feeding
D005247	Feeding Behavior
D001519	Behavior