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

Phase 3

Completed

• Conditions: Foetal Growth Problem; Small for Gestational Age

• Registration Number: NCT00184691
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-04
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect on Efficacy: Height SDS for chronological age	after 48 months
Safety: Bone maturation and glucose metabolism

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Sevilla, Spain