Assessment of Annabella Breast Pump Performance

Breast Feeding Clinical Trial

Official title:

Assessment of Annabella Breast Pump Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363073
• Other study ID #: Annabella V1
• Status: Completed
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Annabella Tech Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 31, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Device:
• Annabella Breast Pump
Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart)
• Control Breast Pump
Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart)

Locations

Country	Name	City	State
Israel	Shamir medical center	Be'er Ya'aqov

Sponsors (1)

Lead Sponsor	Collaborator
Annabella Tech Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Milk Volume collected using the breast pump	Total milk Volume (cc)	immediately after the intervention
Secondary	Satisfaction Satisfaction questionnaires	rating scale: Min: 1 , Max: 10; higher score- better outcome	immediately after the intervention