title: Recombinant human prolactin for the treatment of lactation insufficiency.
abstract: BACKGROUND
  Lactation insufficiency has many aetiologies including complete or relative prolactin deficiency. Exogenous prolactin may increase breast milk volume in this subset. We hypothesized that recombinant human prolactin (r-hPRL) would increase milk volume in mothers with prolactin deficiency and mothers of preterm infants with lactation insufficiency.
  
  
  METHODS
  Study 1: R-hPRL was administered in an open-label trial to mothers with prolactin deficiency. Study 2: R-hPRL was administered in a randomized, double-blind, placebo-controlled trial to mothers with lactation insufficiency that developed while pumping breast milk for their preterm infants.
  
  
  METHODS
  Study 1: Mothers with prolactin deficiency (n = 5). Study 2: Mothers of premature infants exclusively pumping breast milk (n = 11).
  
  
  METHODS
  Study 1: R-hPRL (60 μg/kg) was administered subcutaneously every 12 h for 28 days. Study 2: Mothers of preterm infants were randomized to receive r-hPRL (60 μg/kg), placebo or r-hPRL alternating with placebo every 12 h for 7 days.
  
  
  METHODS
  Change in milk volume.
  
  
  RESULTS
  Study 1: Peak prolactin (27·9 ± 17·3 to 194·6 ± 19·5 μg/l; P < 0·003) and milk volume (3·4 ± 1·6 to 66·1 ± 8·3 ml/day; P < 0·001) increased with r-hPRL administration. Study 2: Peak prolactin increased in mothers treated with r-hPRL every 12 h (n = 3; 79·3 ± 55·4 to 271·3 ± 36·7 μg/l; P < 0·05) and daily (101·4 ± 61·5 vs 178·9 ± 45·9 μg/l; P < 0·04), but milk volume increased only in the group treated with r-hPRL every 12 h (53·5 ± 48·5 to 235·0 ± 135·7 ml/day; P < 0·02).
  
  
  CONCLUSIONS
  Twice daily r-hPRL increases milk volume in mothers with prolactin deficiency and in preterm mothers with lactation insufficiency.
authors: Harvard Medical School Reproductive Endocrine Unit, Brigham and Women's Hospital, Boston University Medical School, Boston, MA, USA.
authors: Camille E
authors: CE
authors: Powe
authors: Maureen
authors: M
authors: Allen
authors: Karen M
authors: KM
authors: Puopolo
authors: Anne
authors: A
authors: Merewood
authors: Susan
authors: S
authors: Worden
authors: Lise C
authors: LC
authors: Johnson
authors: Amy
authors: A
authors: Fleischman
authors: Corrine K
authors: CK
authors: Welt
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007775:Lactation Disorders / Q000188:drug therapy*; D008895:Milk, Human; D010865:Pilot Projects; D011388:Prolactin / Q000097:blood / Q000172:deficiency / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D011994:Recombinant Proteins; D011388:Prolactin