Aims. To determine the galactopoietic response to recombinant human gr
owth hormone (hGH) in mothers of premature infants with inadequate lac
tation. Study Design. Prospective placebo-controlled, double-blind tri
al. Subjects. Twenty healthy mothers on no concurrent medication, with
infants born between 26 and 34 weeks' gestation with insufficient mil
k production for their infants' needs. Interventions. Ten mothers rece
ived hGH,.2 IU/kg/ day subcutaneously to a maximum of 16 IU/day, for 7
days, while 10 mothers received the same volume of placebo. One mothe
r from each group withdrew from the study. Outcome Measures. Maternal
milk production and plasma concentrations of insulin-like growth facto
r-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), a
nd growth hormone (GH) were determined before starting treatment and 1
day after stopping therapy. A nurse measured the amount of milk expre
ssed (5 to 6 times daily) plus, if the infant was suckling, weighed th
e infant before and after feeding. Results. The mothers were enrolled
35 +/- 26 days after birth; at this time the infants weighed 1.89 +/-
.64 kg. Milk production in hGH-treated mothers increased from 139 +/-
49 mL/day to 175 +/- 46 mL/day after 7 days of treatment (a rise of 31
%). Placebo-treated mothers showed no significant change from 93 +/- 5
0 mL/day to 102 +/- 69 mL/day (a rise of 7.6%, not significant). Milk
production increased in all treated mothers but decreased in 4 of 9 pl
acebo mothers. Plasma concentrations of IGF-1 and IGFBP-3 increased in
hGH-treated mothers but not placebo-treated mothers; there was no cha
nge in plasma GH levels in either group. No adverse effects were seen
with hGH treatment in the mothers or infants. Conclusions. hGH therapy
in mothers with lactational insufficiency can improve breast milk vol
umes.