Assessment of Annabella Breast Pump Performance

NCT ID: NCT04363073

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2023-12-31

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.

Conditions

Breast Feeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Anaabella

Milk will be expressed using Annabella breast pump.

Group Type: EXPERIMENTAL

Annabella Breast Pump

Intervention Type: DEVICE

Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart)

Control pump

Milk will be expressed using a control breast pump.

Group Type: ACTIVE_COMPARATOR

Control Breast Pump

Intervention Type: DEVICE

Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart)

Interventions

Annabella Breast Pump

Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart)

Intervention Type: DEVICE

Control Breast Pump

Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart)

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Annabella Tech Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Revital Sheinberg, MD

Role: PRINCIPAL_INVESTIGATOR

Shiba Medical Center, Israel

Locations

Shamir medical center

Be’er Ya‘aqov, , Israel

Countries

Israel

Other Identifiers

Annabella V1

Identifier Type: -

Identifier Source: org_study_id