Clinical trial NCT04363073: Assessment of Annabella Breast Pump Performance
Official title: Assessment of Annabella Breast Pump Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Keywords: Breast Feeding
Lead sponsor: Annabella Tech Ltd
Sponsor class: INDUSTRY
First posted: 2020-04-27
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Milk Volume collected using the breast pump
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Satisfaction Satisfaction questionnaires
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir medical center
Study officials:
affiliation: Shiba Medical Center, Israel
name: Revital Sheinberg, MD
role: PRINCIPAL_INVESTIGATOR
References: