Improvement in growth after 1 year of growth hormone therapy in well-nourished infants with growth retardation secondary to chronic renal failure: results of a multicenter, controlled, randomized, open clinical trial.
OBJECTIVE
Our aim was to evaluate the growth-promoting effect of growth hormone (GH) treatment in infants with chronic renal failure (CRF) and persistent growth retardation despite adequate nutritional and metabolic management.


METHODS
The study design included randomized, parallel groups in an open, multicenter trial comparing GH (0.33 mg/kg per wk) with nontreatment with GH during 12 months. Sixteen infants who had growth retardation, were aged 12+/-3 months, had CRF (GFR<or=60 ml/min per 1.73 m2), and had adequate nutritional intake and good metabolic control were recruited from eight pediatric nephrology departments from Spain and Portugal. Main outcome measures were body length, body weight, bone age, biochemical and hormonal analyses, renal function, bone mass, and adverse effects.


RESULTS
Length gain in infants who were treated with GH was statistically greater (P<0.05) than that of nontreated children (14.5 versus 9.5 cm/yr; SD score 1.43 versus -0.11). The GH-induced stimulation of growth was associated with no undesirable effects on bone maturation, renal failure progression, or metabolic control. In addition, GH treatment improved forearm bone mass and increased serum concentrations of total and free IGF-I and IGF-binding protein 3 (IGFBP-3), whereas IGF-II, IGFBP-1, IGFBP-2, GH-binding protein, ghrelin, and leptin were not modified.


CONCLUSIONS
Infants with CRF and growth retardation despite good metabolic and nutritional control benefit from GH treatment without adverse effects during 12 months of therapy.
Department of Pediatric Nephrology, Hospital Universitario Central de Asturias, Universidad de Oviedo, Celestino Villamil, s/n, E33006 Oviedo, Spain. fsantos@uniovi.es
Fernando
F
Santos
M Llanos
ML
Moreno
Arlete
A
Neto
Gema
G
Ariceta
Julia
J
Vara
Angel
A
Alonso
Alberto
A
Bueno
Alberto Caldas
AC
Afonso
António Jorge
AJ
Correia
Rafael
R
Muley
Vicente
V
Barrios
Carlos
C
Gómez
Jesús
J
Argente
D015502:Absorptiometry, Photon; D050280:Arm Bones / Q000000981:diagnostic imaging / Q000187:drug effects / Q000254:growth & development; D015415:Biomarkers / Q000097:blood; D001827:Body Height / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D015519:Bone Density / Q000187:drug effects; D016009:Chi-Square Distribution; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005919:Glomerular Filtration Rate; D006130:Growth Disorders / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D019382:Human Growth Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D009752:Nutritional Status; D011174:Portugal; D011446:Prospective Studies; D011863:Radioimmunoassay; D013030:Spain; D013639:Tarsal Bones / Q000000981:diagnostic imaging / Q000187:drug effects / Q000254:growth & development; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers; D019382:Human Growth Hormone