LONG TERM TREATMENT OF BURNED CHILDREN W/ RECOMBINANT HUMAN GROWTH HORMONE

点击翻译按钮获取中文摘要

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 >40% 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. The study consists of an acute-inpatient phase and rehabilitation-outpatient phase(this proposal). Four Shriners Hospitals for Children - Burn Institutes will participate. We hypothesize that treatment with rhGH over a one-year period post-burn will enhance linear growth, bone density and muscle. Using minimally invasive state-of-the-art techniques, we will evaluate 30 (total enrollment from all centers) post-burn patients per year in a double-blind study 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 (multi-center) 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.