Clinical trial NCT00184691: Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years
Official title: Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone Which Will be Started Randomly at the Ages of 2 to 5, in Children Diagnosed of IUGR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Foetal Growth Problem
Small for Gestational Age
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 78
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.


Eligibility criteria: Inclusion Criteria:

* IUGR defined as birth length and/or weight below the lower limit (\< P10) of the Lubchenco curves for the gestational age.
* Chronological age = 2-5 years
* HV below average for CA
* Insufficient catch-up growth (Height \< P3 for chronological age, according to Hernández)
* Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother
* Normal response to GH stimulation test (greater tan or equal to 10 ng/mL)
* Bone age (measured through Greulich and Pyle method) less than or equal to CA

Exclusion Criteria:

* Children born from multiple pregnancy
* Children with post-ischemic encephalopathy
* Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.)
* Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy)
* Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....)
* Nutritional disorders (celiac disease) or osteodystrophies
* Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects
* Abnormal karyotype
* Neoplasms
* Previous or ongoing chemotherapy and/or irradiation
* Renal dysfunction, defined as serum creatinine \> 1 mg/dL

Primary outcomes:
measure: Effect on Efficacy: Height SDS for chronological age
timeFrame: after 48 months
measure: Safety: Bone maturation and glucose metabolism
Secondary outcomes:
measure: Efficacy: Height SDS for bone age; Height velocity SDS for bone age; Height velocity SDS for chronological age; Serum IGF-I and IGFBP-3 levels
Other outcomes:
Locations:
city: Baracaldo
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Cádiz
country: Spain
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Spain
facility: Novo Nordisk Investigational Site
city: El Palmar
country: Spain
facility: Novo Nordisk Investigational Site
city: Esplugues Llobregat
country: Spain
facility: Novo Nordisk Investigational Site
city: Granada
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novo Nordisk Investigational Site
city: Santiago de Compostela
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Argente J, Gracia R, Ibanez L, Oliver A, Borrajo E, Vela A, Lopez-Siguero JP, Moreno ML, Rodriguez-Hierro F; Spanish SGA Working Group. Improvement in growth after two years of growth hormone therapy in very young children born small for gestational age and without spontaneous catch-up growth: results of a multicenter, controlled, randomized, open clinical trial. J Clin Endocrinol Metab. 2007 Aug;92(8):3095-101. doi: 10.1210/jc.2007-0078. Epub 2007 May 29.