Objective To determine the safety and efficacy of recombinant human gr
owth hormone (rhGH) in the treatment of children who are severely burn
ed. Summary Background Data During the last decade, we have used recom
binant human growth hormone (rhGH; 0.2 mg/kg/day SQ) to successfully t
reat 130 children with more than 40% total body surface area (TBSA) bu
rns to enhance wound healing and decrease protein loss, A significant
increase in the mortality of adult patients in the intensive care unit
who were given rhGH has recently been reported In two large European
trials which questions the therapeutic safety of rhGH. Methods The rec
ords of 263 children who were burned were reviewed. Patients receiving
either rhGH at 0.2 mg/kg/day subcutaneously as part of a randomized c
linical trial (n = 48) or therapeutically (n = 82) were compared with
randomized placebo-administered controls (n = 54), contiguous matched
controls (n = 48), and matched patients admitted after August 1997, af
ter which no patients were treated with rhGH (n = 31). Morbidity and m
ortality, which might be altered by rhGH therapy, were considered with
specific attention to organ function or failure, infection, hemodynam
ics, and calcium, phosphorous, and albumin balance. Results A 2% morta
lity was observed in both rhGH and saline placebo groups in the contro
lled studies, with no differences in septic complications, organ dysfu
nction, or heart rate pressure product identified. in addition, no dif
ference in mortality could be shown for those given rhGH therapeutical
ly versus their controls. No patient deaths were attributed to rhGH in
autopsies reviewed by observers blinded to treatment. Hyper glycemic
episodes and exogenous insulin requirements were higher among rhGH rec
ipients, whereas exogenous albumin requirements and the development of
hypocalcemia was reduced. Conclusions Data indicate that rhGH used in
the treatment of children who were severely burned is safe and effica
cious.