Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00184691

Enrollment

Registered

2005-09-16

Start date

1999-04-30

Completion date

2005-06-30

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foetal Growth Problem, Small for Gestational Age

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.

Interventions

DRUGsomatropin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Effect on Efficacy: Height SDS for chronological age	after 48 months
Safety: Bone maturation and glucose metabolism	—

Secondary

Measure	Time frame
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	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026