Status:
COMPLETED
Assessment of Annabella Breast Pump Performance
Lead Sponsor:
Annabella Tech Ltd
Conditions:
Breast Feeding
Eligibility:
FEMALE
18+ years
Phase:
NA
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. Ea...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04363073
Start Date
December 30 2020
End Date
December 31 2023
Last Update
March 26 2024
Active Locations (1)
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1
Shamir medical center
Be’er Ya‘aqov, Israel