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Primo-Lacto Study Results

Posted June 9, 2017 | Leave a Comment by Jules

Primo-Lacto uses the new ENFit connector

Maternal Life LLC, my company, has recently completed a clinical pilot study on Primo-Lacto at three different hospitals: Sharp Mary Birch in San Diego, CA, John Muir Hospital in Walnut Creek, CA, and Indiana Memorial Hospital in South Bend, IN.

To analyze the results, I included data sets from 69 mothers from whom complete data was available. There were 91 nurses that completed full data sets. Mothers with no milk expression were also excluded from analysis. The data analysis was completed by a third party with no prior knowledge or involvement in the study. Taylor Brown holds a B.S. in Biology from Stanford University and is a current medical student at Harvard Medical School.

Patient Perspective

Across all methods, mothers found the combination of hand expression funnel and syringe (Primo-Lacto) the easiest to use (F=8.68, p<.001). The combination of pump, adapter and syringe (Primo-Lacto) was found to be the most satisfying (F=9.16, p<.001) and gave mothers the most confidence (F=7.54, p<.001). Based on comments submitted by the mothers, it appears the pump, adapter and syringe “ease of use” scores were brought down by events involving the syringe coming detached from the pump. *You see F values here because this analysis, the comparison of means across four different treatments was done using a one-way ANOVA* (an analysis of variance). This problem has been addressed in the final design.

Compared to hand expression alone, the introduction of the funnel and syringe (Primo-Lacto) significantly improved mother’s confidence (t=4.23, p<.001) and satisfaction (t=5.39, p<.001) by 25% and 23% respectively. Mothers found this method easier to use by 22% (t=4.48, p<.001). Compared to standard pumping, the introduction of the adapter and syringe attachment (Primo-Lacto) decreases ease of use by 6% (t=1.90, p=.03). As noted above, this is mainly due to events involving the syringe detaching while pumping. The syringe attachment (Primo-Lacto) did significantly improve patient satisfaction (t=2.19, p=.01) and confidence in collection (t=4.23, p=.002) by 12% and 11% respectively.

Nurse Perspective

Overall, nurses perceived hand expression with the funnel and syringe (Primo-Lacto) to be the easiest method, as well as the fastest method of colostrum collection.

Compared to hand expression alone, the addition of the funnel and syringe (Primo-Lacto) significantly improved the ease of colostrum collection by 34% (t=6.42, p<.001). Nurses observed that mothers lost 43% less colostrum compared to regular hand expression (t=2.48, p=.007). Although nurses observed a slight time savings using the syringe (Primo-Lacto), the results were not significant (t=0.68, p=.25).

The adapter and syringe attachment with the breast pump (Primo-Lacto) improved ease of colostrum collection by 32% (t=5.98, p<.001). Nurses observed a 31% reduction in colostrum loss when the adapter and syringe attachment (Primo-Lacto) was used with the breast pump, however the results were not statistically significant (t=1.34, p=.08). Additionally, nurses observed an 8% reduction in collection time (t=1.34, p=.05), again the results were not significant. Many questionnaires were excluded from the analysis for non-completion, which may affect these results.



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