Assessment of Annabella Breast Pump Performance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Annabella Breast Pump Performance

Conditions
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Breast Feeding

Intervention / Treatment
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* Device: Annabella Breast Pump
* Device: Control Breast Pump


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anaabella<br>Milk will be expressed using Annabella breast pump. | Device: Annabella Breast Pump<br>* Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart)<br>|
| Active Comparator: Control pump<br>Milk will be expressed using a control breast pump. | Device: Control Breast Pump<br>* Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Milk Volume collected using the breast pump | Total milk Volume (cc) | immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Content | Fat % | immediately after the intervention | 
| s Satisfaction questionnaires | rating scale: Min: 1 , Max: 10; higher score- better outcome | immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Feeding