Assessment of Annabella Breast Pump Performance

This is an interventional, prospective, randomized, comparative, two-period cross over study to evaluate the performance of Annabella breast pump against a control breast pump.

Study Overview

• Status: Completed
• Conditions: Breast Feeding
• Intervention / Treatment: Device: Annabella Breast Pump; Device: Control Breast Pump

Detailed Description

50 women who are 2-5 months post-delivery will be included in the study following appropriate consent. Women will be randomly allocated to two groups for the type of pump used on the first session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. During each visit, milk will be expressed once a day from each of the two breasts (left & right). During the 4 first visits (at least 1 day apart) Annabella or the control pump will be used. After at least 3 days washout period, milk will be expressed for additional 4 days, once a day from each of the two breasts, using the other breast pump. An expression session will last until no milk is expressed for 3 min continuously but not for longer than 25 min. Participants will be serving as their own control. Milk will be collected for volume and quality assessment. Maternal comfort at the end of each visit will be assessed using questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er Ya'aqov, Israel
    • Shamir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women ≥ 18 years old
• Women whom are 2-5 months post delivery
• Lactating women - Breastfeed with no more than formula feeding twice a day and no solid food feeding (which replace breastfeeding) during the study period.
• Breastfeed or pumping at least 5 times a day
• Mother to healthy infant born at ≥ 37 weeks of gestation age.

Exclusion Criteria:

• Woman who consumes under 1,500 kcal/day (on a diet)
• Report a high mental stress condition and/or depression
• Use of estrogen oral contraceptives
• Pregnant women
• Suffer from chronic diseases that can impact breast feeding
• Participate in another clinical trial
• Mothers of babies who may develop feeding difficulties according to the investigator decisions (such as cleft pallet, autism).
• Woman with Sunken/ flat nipple or inverted nipple. or any other physiological condition that may disturb breast feeding.
• Woman that declares at time of recruitment that she is unable to extract more than 25ml per breastfeeding (overall from both breast)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anaabella; Milk will be expressed using Annabella breast pump.	Device: Annabella Breast Pump; Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart)
Active Comparator: Control pump; Milk will be expressed using a control breast pump.	Device: Control Breast Pump; Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Milk Volume collected using the breast pump	Total milk Volume (cc)	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction Satisfaction questionnaires	rating scale: Min: 1 , Max: 10; higher score- better outcome	immediately after the intervention

Collaborators and Investigators

• Sponsor: Annabella Tech Ltd
• Investigators: Principal Investigator: Revital Sheinberg, MD, Shiba Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Breast Feeding
• Other Study ID Numbers: Annabella V1

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: No