WHAT'S KNOWN ON THIS SUBJECT:The direct effects of prolactin on the nutritional and antimicrobial composition of breast milk have not been examined previously in women.
WHAT THIS STUDY ADDS:The study demonstrates that recombinant human prolactin increases milk volume, induces changes in milk composition consistent with those during normal lactogenesis, and increases antimicrobially active oligosaccharide concentrations. The data suggest that prolactin is an important mediator of normal lactogenesis. abstract OBJECTIVE: The objective of this study was to determine the impact of recombinant human prolactin (r-hPRL) on the nutritional and immunologic composition of breast milk.
METHODS:We conducted 2 trials of r-hPRL treatment. In the first study, mothers with documented prolactin deficiency were given r-hPRL every 12 hours in a 28-day, open-label trial. In the second study, mothers with lactation insufficiency that developed while they were pumping breast milk for their preterm infants were given r-hPRL daily in a 7-day, double-blind, placebo-controlled trial. Breast milk characteristics were compared before and during 7 days of treatment.
RESULTS:Among subjects treated with r-hPRL (N ϭ 11), milk volumes (73 Ϯ 36 to 146 Ϯ 54 mL/day; P Ͻ .001) and milk lactose levels (155 Ϯ 15 to 184 Ϯ 8 mmol/L; P ϭ .01) increased, whereas milk sodium levels decreased (12.1 Ϯ 2.0 to 8.3 Ϯ 0.5 mmol/L; P ϭ .02). Milk calcium levels increased in subjects treated with r-hPRL twice daily (2.8 Ϯ 0.6 to 5.0 Ϯ 0.9 mmol/L; P ϭ .03). Total neutral (1.5 Ϯ 0.3 to 2.5 Ϯ 0.4 g/L; P ϭ .04) and acidic (33 Ϯ 4 to 60 Ϯ 6 mg/L; P ϭ .02) oligosaccharide levels increased in r-hPRL-treated subjects, whereas total daily milk immunoglobulin A secretionwas unchanged.CONCLUSIONS: r-hPRL treatment increased milk volume and induced changes in milk composition similar to those that occur during normal lactogenesis. r-hPRL also increased antimicrobially active oligosaccharide concentrations. These effects were achieved for women with both prolactin deficiency and lactation insufficiency.