1. Small for gestational age (SGA)
Conditions
Interventions
Growth hormone treatment in either 3 or 6 IU (~1 or 2 mg)/m2/day (randomized double-blind dose-response trial).
Sponsors
Novo Nordisk A/S, Denmark
Eligibility
Inclusion criteria
Inclusion criteria: 1. Birth length = P3 (Roede), within the first two years of life or at a later stage; 4. Height velocity (HV) (cm/year) for chronological age <= P50 (Tanner); 5. Chronological age at start of treatment: girls: 3.00 to 8.99 years; boys: 3.00 to 10.99 years; 6. Prepubertal signs as defined by Tanner stage 1 or testicular volume <4 ml; 7. Well documented growth data from birth up to two years and at least one year before start of treatment; 8. Written informed consent from child and/or parents/guardians.
Exclusion criteria
Exclusion criteria: 1. Any endocrine or metabolic disorder (such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism); 2. Disorders of the genito-urinary tract, cardio-pulmonary or gastro-intestinal tract, or nervous system, nutritional and/or vitamin deficiencies; 3. Chromocomal abnormalities or signs of a syndrome, except for Silver-Russel syndrome; 4. Chondrodysplasia; 5. Hydrocephalus; 6. Subjects with active malignant diseases or with increased risk of leukaemia; 7. Serious suspicion of psychosocial dwarfism (emotional deprivation); 8. Previous anabolic sex steroid or GH therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the effect of GH therapy on: a. linear growth; b. bone maturation; c. pubertal development; d. final height; in children with IUGR and no catch-up growth. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the relation between 24-hour plasma GH profiles and the effect of GH therapy with two doses of GH; 2. To assess the additional affects of GH therapy on glucose and lipid metabolism, blood pressure, procollagen-I and III, plasma IGF-I and IGF-binding protein 3 (IGFBP-3); 3. Psychosocial functioning; 4. Intelligence. | — |
Contacts
Public ContactA.C.S. Hokken-Koelega
Erasmus Medical Center, Sophia Children's Hospital, Room number SP-3437, P.O. Box 2060
Outcome results
None listed