Assessment of Annabella Breast Pump Performance

Not Applicable

Completed

• Conditions: Breast Feeding
• Interventions: Device: Annabella Breast Pump; Device: Control Breast Pump

• Registration Number: NCT04363073
• Lead Sponsor: Annabella Tech Ltd

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Study Start: 2020-12-30
• Primary Completion: 2023-04-01
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anaabella	Annabella Breast Pump	Milk will be expressed using Annabella breast pump.
Control pump	Control Breast Pump	Milk will be expressed using a control breast pump.

Primary Outcome Measures

Name	Time	Method
Milk Volume collected using the breast pump	immediately after the intervention	Total milk Volume (cc)

Secondary Outcome Measures

Name	Time	Method
Satisfaction Satisfaction questionnaires	immediately after the intervention	rating scale: Min: 1 , Max: 10; higher score- better outcome

Trial Locations

Locations (1)

Shamir medical center; 🇮🇱 Be'er Ya'aqov, Israel