Assessment of Annabella Breast Pump Performance

Launched by ANNABELLA TECH LTD · Apr 23, 2020

Keywords

ClinConnect Summary

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....

Gender

FEMALE

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)