Introduction

Health experts worldwide recognize breastmilk as the superior infant food. Recommendations from the American Academy of Pediatrics and the World Health Organization (WHO) identify exclusive breastfeeding for the first half-year of life and continuation of breastfeeding into toddlerhood as offering maximum protection from illness, providing a substrate for immunological protection.

In the United States (US), approximately 85% of mothers with healthy newborn infants, express milk within the first four months post-birth, and the majority will do so using a breast pump.

A natural baby suckling motion comprises both suction on the breast and nipple and areola compression with tongue motion. Most electrically powered breast pumps currently in the market use vacuum pressure only to remove milk from the breast.

Annabella has developed a revolutionary breast pump that utilizes vacuum pressure as well as an additional mechanism simulating the tongue movements that massage the nipple and areola to dramatically improve the milk expression and user experience.

The aim of this study was to demonstrate the performance of Annabella electric breast pump by measuring the total milk volume expressed from the breast, when compared to a leading band standard breast pump, which utilizes vacuum pressure only.

Investigational Plan

This was a prospective, two-arm, two-period crossover study designed to assess the performance and safety of the Annabella breast pump versus a Control breast pump in women who were lactating and 2-5 months post-delivery.

The study included women with normal full-term infants that have successfully breastfed with no more than two formula feedings a day and no solid food intake.
Women were randomly allocated in a 1:1 ratio to one of the two sequences:
• Sequence A - Session 1 (four visits) – Annabella; Session 2 (four visits)– Control Pump.
• Sequence B - Session 1 (four visits) – Control Pump; Session 2 (four visits) – Annabella.

Each session consisted of 4 visits, at least 1 day apart. During each visit, milk was expressed once a day from each of the two breasts (left and right). The expression started at least 1 hour after the end of a regular baby feeding session. A breast milk expression lasted until no milk was expressed for 3 minutes continuously but no longer than 25 minutes per breast.

Each expression visit started with the opposite breast side used to breastfeed the baby before the visit. Milk collected for the study was not used to feed the babies. Questionnaires were used at the end of each visit to assess subject satisfaction from each pump.

Study Objectives
The overall objective of this study was to assess the performance of the Annabella pump as compared to a control breast pump.

Primary Objective:
The primary objective of the study was to compare the Annabella breast pump performance as measured by total volume of milk expressed versus a control breast pump (a leading brand).

Secondary Objective:
The secondary objective of the study was to compare the user’s satisfaction between Annabella breast pump to the Control breast pump.

Results

Subject Disposition
In this study, 52 subjects were randomized and included in FAS analysis set. Of these, 7 had prematurely terminated their participation. Out of them, 1 subject had at least 2 valid visits, and was included in the mFAS analysis set with the other 45 subjects. Of these, 40 subjects had 8 valid visits and therefore completed the study per protocol.

Baseline Characteristics
Subjects’ ages ranged between 23 – 42 years, with an average of 31 years. Subjects’ BMI varied between 17.9 – 46.8, with the average of 26.8 kg/m2. Almost all of the subjects were married (97.8%). Most of the subjects had 1 or 2 children (82.7%); most had a normal delivery (78.3%). No subject had consumed alcohol or more than 4 cups of coffee per day during the study, and only 1 subject had smoked. Fifty (50)% used food supplements and most did not use concomitant medications (>89%).

Infants were born between week 37 – 41.5, with an average of 39.3 weeks. Infants’ weight varied between 2615 – 3915 grams, with an average weight of 3258.9 grams.

Safety

Two adverse events (AEs) occurred during the study. Both AEs were determined as non-serious, unrelated to the device and resolved spontaneously.

Milk Expression Characteristics
All study subjects at all visits consumed at least 1500 Kcal/day. Almost all study subjects (97% in Annabella and 93% in Medela) reported that they had slept at least 6 hours across all 4 visits. Most infants were not fed with formula (82.8%-87%) and none of them had solid food intake during the study. About 80% of subjects used another pump at home.

The milk expression conditions were very similar between the Annabella sessions and Medela sessions.

Primary Efficacy Analysis
The average milk quantity expressed by Annabella ranged from 36.5 gr to 246.5 gr, with an average of 135.4 gr. The average milk quantity expressed by the control pump ranged from 12 gr to 212.8 gr, with an average of 92.2 gr.
Hypothesis test yielded the average ratio of 1.5, indicating the average increase of 50% in milk expression, with the 95% confidence interval of (1.3, 1.6), with p-value <0.0001.
Thus, the primary hypothesis has been demonstrated successfully, showing a significant increase in milk expression with the Annabella pump when compared to the control pump.

Secondary Efficacy Analysis
The secondary analysis examined the satisfaction of subjects with the pumps. Seven (7) satisfaction items were examined on a scale of 1-10 (with 1 indicating lowest satisfaction and 10 indicating highest satisfaction). For two items, the scores reported for the Annabella breast pump were significantly higher than the scores reported for the control breast pump. “The Suction Sensation While Pumping Is Pleasant” scored 9.6 for the Annabella breast pump and 7.1 for the control pump and “I Believe the Pump Is Effective” scored 9.5 for the Annabella breast pump and 6.4 for the control pump.

For one item, “The Pump Is Easy to Hold While Pumping”, the score reported for the Annabella breast pump was somewhat lower compared to the score reported for the control breast pump (6.7 vs. 8.0).
For the remaining items the scores were similar.

Conclusions

The primary efficacy hypothesis of the study has been met. The study has successfully demonstrated the safety and performance of the Annabella breast pump with an increase of 1.5 in milk expression on average versus the control breast pump in women who were lactating and 2-5 months post-delivery.

“The Shamir Medical Center in Israel conducted the clinical trial under the leadership of Dr. Revital Scheinberg, Head of the Risk Management and Patient Safety Unit”