RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Validation of the Ameda Pearl Breast Pump

Quick Facts

Study Start:2022-07-21

Study Completion:2023-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05297799

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Susan M Shondel, MD

CONTACT

330-571-9889

shondels@summahealth.org

Principal Investigator

Susan M Shondel, MD

PRINCIPAL_INVESTIGATOR

Summa Health

Study Locations (Sites)

Summa Health

Akron, Ohio, 44304

United States

Collaborators and Investigators

Sponsor: Ameda, Inc.

Susan M Shondel, MD, PRINCIPAL_INVESTIGATOR, Summa Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-21

Study Completion Date2023-09

Study Record Updates

Study Start Date2022-07-21

Study Completion Date2023-09

Terms related to this study

Additional Relevant MeSH Terms

Breast Pumping