Effects of recombinant human prolactin on breast milk composition.
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 = 11), milk volumes (73 ± 36 to 146 ± 54 mL/day; P < .001) and milk lactose levels (155 ± 15 to 184 ± 8 mmol/L; P = .01) increased, whereas milk sodium levels decreased (12.1 ± 2.0 to 8.3 ± 0.5 mmol/L; P = .02). Milk calcium levels increased in subjects treated with r-hPRL twice daily (2.8 ± 0.6 to 5.0 ± 0.9 mmol/L; P = .03). Total neutral (1.5 ± 0.3 to 2.5 ± 0.4 g/L; P = .04) and acidic (33 ± 4 to 60 ± 6 mg/L; P = .02) oligosaccharide levels increased in r-hPRL-treated subjects, whereas total daily milk immunoglobulin A secretion was 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.
Harvard Medical School, Harvard University, Boston, Massachusetts 02114, USA.
Camille E
CE
Powe
Karen M
KM
Puopolo
David S
DS
Newburg
Bo
B
Lönnerdal
Ceng
C
Chen
Maureen
M
Allen
Anne
A
Merewood
Susan
S
Worden
Corrine K
CK
Welt
D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007775:Lactation Disorders / Q000097:blood / Q000188:drug therapy; D008895:Milk, Human / Q000737:chemistry / Q000378:metabolism*; D010865:Pilot Projects; D047928:Premature Birth / Q000097:blood / Q000188:drug therapy; D011388:Prolactin / Q000097:blood* / Q000172:deficiency* / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000097:blood / Q000627:therapeutic use
D011994:Recombinant Proteins; D011388:Prolactin
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