Preliminary data from a multicenter trial using recombinant human growth hormone (rhGH) in the treatment of children with severe thermal injury suggests that accelerated wound healing and improved protein metabolism occurs with this treatment. These distinct effects of improving protein kinetics after a major physiologic stressor represent a capital gain in the progress against hypercatabolism-associated morbidity and mortality. At present, there are no preliminary data on the long-term administration of rhGH in this patient population. However, the long term sequelae of children suffering a greater than 40 percent total body surface area burn include a reduction in growth velocity up to 3 years post-burn with permanent stunting. This is a proposal to proceed with the outpatient phase of the current rhGH study (Long-term Treatment of Severely Burned Treatment of Severely Burned Children With Recombinant Human Growth Hormone: A Multi-center Trial; SHC grant number 15877; Continuation number 8770). The study consists of an acute- inpatient phase and rehabilitation-outpatient phase (this proposal). Patients admitted to Shriners Hospitals for Children - Burn Hospital at Galveston will participate. We hypothesize that treatment with rhGH over a one year period post-burn will enhance linear growth, bone density and muscle strength. Using state-of-the-art techniques, we will evaluate 50 post-burn patients per year in a double-blind study (25 treated with rhGH and 25 with placebo) to determine the overall impact of long term rhGH administration. Specifically, we aim to identify any biochemical or physiological evidence for persistent after initial hospital discharge of the catabolic state caused by burn injury. This will be the first, large study on growth distribution and bone density and will serve as future reference for studies addressing other treatment approaches in the post- burn population. Finally, the long term efficacy of rhGH administration in the post-burn population with respect to acceleration of growth velocity, whole body protein synthesis, skeletal muscle mass and restoration of normal bone density will be established.
| Tuvdendorj, Demidmaa; Chinkes, David L; Zhang, Xiao-Jun et al. (2011) Skeletal muscle is anabolically unresponsive to an amino acid infusion in pediatric burn patients 6 months postinjury. Ann Surg 253:592-7 |
