This SR highlights the lack of long-term RCTs reporting final height data and other important qualitative outcomes , such as quality of life .
ABSTRACT Genotropin ( somatropin ) is licensed for the treatment of children with growth hormone deficiency , Prader-Willi syndrome , Turner syndrome , chronic renal insufficiency and in children born small for gestational age .
This systematic review ( SR ) evaluated the clinical efficacy and effectiveness of Genotropin in these conditions to inform a NICE Technology Appraisal of growth hormone for the treatment of growth failure in children .
High‐dose growth hormone therapy for short children born small for gestational age
The growth-promoting effect of recombinant human growth hormone ( GH ; Genotropin ' ) therapy in short children born small for gestational age was evaluated in a r and omized , open-labelled , multicentre trial . Three parallel groups were recruited : group 1 was an untreated control group ; group 2 received  recombinant human GH , 0.2 IU/kg/day s.c . , and group 3 received recombinant human GH , 0.3 IU/kg/day S.C. Treatment was continued for 24 months . The inclusion criteria were : weight and /or length at birth below -2 SD for gestational age ; chronological age 2 - 8 years ; height/chronological age below -2.5 SD ; height velocity below + 1 SD ; and a serum G H concentration of at least 10 & I after exercise , glucagon administration or insulin-induced hypoglycaemia . The dose of G H was adjusted for body weight every 6 months . Preliminary 18-month data from 46 of the 51 children followed are reported here . This cohort consists of short children who suffered from idiopathic or non-syndromic intrauterine growth retardation ( n = 31 ) and children with either Silver-Russell syndrome ( n = 9 ) , Dubowitz syndrome ( n = 3 ) or fetal alcohol syndrome ( n = 3 ) .  Weight at birth was 1.99 k 0.08 kg ( mean i SEM ) , length at birth was 42.4 k 0.6 cm and gestational age was 37.9 f 4 weeks . At the start of the study , chronological age was 5.1 k 0.3 years , bone age ( Tanner-Whitehouse 2 method ) 3.9 k 0.3 years , height velocity 6.9 k 0.3 cdyears , height velocity for chronological age -0.7 i 0.1 SD , height for chronological age -3.5 k 0.1 SD , and height for bone age -1.5 k 0.3 SD . At the start , groups 1 , 2 and 3 did not differ significantly for any of the variables assessed . Salient 18-month growth data are summarized in Table 1 . The recombinant human GH therapy did not appear to be associated with any clinical adverse events . All children remained prepubertal during the study period . The fasting serum insulin concentrations were measured after 12 months and were found to be twice as high in children treated with G H ( approximately 20 mU/l ) compared with pretreatment levels or with those of untreated children
This SR highlights the lack of long-term RCTs reporting final height data and other important qualitative outcomes , such as quality of life .
ABSTRACT Genotropin ( somatropin ) is licensed for the treatment of children with growth hormone deficiency , Prader-Willi syndrome , Turner syndrome , chronic renal insufficiency and in children born small for gestational age .
This systematic review ( SR ) evaluated the clinical efficacy and effectiveness of Genotropin in these conditions to inform a NICE Technology Appraisal of growth hormone for the treatment of growth failure in children .