Foetal Growth Problem, Small for Gestational Age
Conditions
Brief summary
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.
Interventions
DRUGsomatropin
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10 * Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study * Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age * Normal response to GH stimulation test (greater than 10 ng/mL)
Exclusion criteria
* Diabetes * Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders) * Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects * History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy * Previous or ongoing growth hormone therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height gain according to birth group, age of onset, the treatment and Tanner stage | during 12 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Height SDS for bone age | during 12 months of treatment |
| Height velocity SDS for bone age | during 12 months of treatment |
| Height velocity for chronological age | during 12 months of treatment |
Countries
Spain
Outcome results
None listed