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APHA Scientific Session and Event Listing

Corrine K. Welt, MD, Gabrielle Page-Wilson, MD, and Patricia C. Smith, BS. Reproductive Endocrine, Massachusetts General Hospital, BHX 511, 55 Fruit Street, Boston, MA 02114, 617-726-8437, cwelt@partners.org

Breastfeeding imparts many advantages to mothers and infants, particularly premature infants who benefit by a decrease in the rate of necrotizing enterocolitis. However, lactation insufficiency is common in mothers of premature infants who must pump breast milk for their infants. There is no FDA approved lactation induction agent. We hypothesized that recombinant human prolactin (r-hPRL) would be biologically active fur use as a possible agent for lactation induction.

Healthy women (n=21) with regular menstrual cycles underwent a 7 day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of bone turnover and gonadal function were measured and side effects recorded.

Prolactin levels increased during r-hPRL administration (20.0±2.8 to 231.7±48.9 ng/mL at 6 hours; p<0.05). Five of nine subjects developed expressible galactorrhea (p<0.001). Urinary deoxypyridinoline decreased and bone specific alkaline phosphatase increased in r-hPRL and placebo groups, while there were no changes in serum estradiol, Ca, phosphorus, PTH, PTH-rP or 1,25-(OH)2 vitamin D concentrations or in urinary Ca/Cr and phosphorus/Cr ratios. Menstrual cycle lengths were not altered with r-hPRL. Side effects were similar between r-hPRL and placebo groups.

These data demonstrate that r-hPRL is biologically active, causing galactorrhea. Seven days of r-hPRL administration does not increase bone resorption or prevent the normal increase in bone formation in the follicular phase of regularly cycling women. These findings suggest that r-hPRL by itself does not exert a detrimental effect on bone turnover or menstrual cyclicity during the short-term administration that would be used for lactation augmentation.

Learning Objectives: The learner in this session should be able to

• Recognize a group at risk for lactation insufficiency.
• Identify the lactogenic potential of recombinant human prolactin.
• Evaluate recombinant human prolactin for treatment of lactation insufficiency.

Keywords: Breast Feeding, Treatment

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: Recombinant human prolactin is under investigational use.

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