Children with persistent short stature (<-2.5 SDS) after being born small for gestational age (birth weight and/or birth length <-2 SDS)
Conditions
Interventions
All children are treated with Genotropin® (recombinant human somatropine, Pharmacia Corp., Peapack, NJ, USA) 1mg/m2/day until final height.
During puberty GH therapy 2 versus 1 mg/m2/day will be eva
Sponsors
Dutch Growth Foundation Westzeedijk 106
3001 KB Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children born with a birth length and/or weight < - 2 SD for gestational age (Usher McLean); 2. Short stature defined in prepubertal children as a height SD score below –2.5 according to the Dutch National Growth References of 1997 or a predicted final height < -2.5 SD score, calculated as the height at start of puberty plus 30 cm for boys and +20 cm for girls; 3. Height velocity (cm/year) for chronological age < P50 in prepubertal children; 4. Chronological age at start of treatment: 8 years or older (boys and girls); 5. Well documented growth data from birth up to 2 years and at least 1 year before the start of the study; 6. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Turner syndrome in girls, known syndromes and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described, except for Silver Russell Syndrome; 2. Severe asphyxia (defined as Apgar score <3 after 5 minutes), and no serious diseases such as long-term artificial ventilation and oxygen supply, bronchopulmonary dysplasia or other chronic lung disease; 3. Coeliac disease and other chronic or serious diseases of the gastrointestinal tract, heart, genito-urinary tract, liver, lungs, skeleton or central nervous system, or chronic or recurrent major infectious diseases, nutritional and/or vitamin deficiencies; 4. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism, except of GHD; 5. Medications or interventions during the previous 6 months that might have interfered with growth, such as corticosteroids (including high dose of corticosteroid inhalation), sex steroids, growth hormone, or major surgery (particularly of the spine or extremities); 6. Use of medication that might interfere with growth during GH therapy, such as corticosteroids, sex steroids, LHRH analogue; 7. Active or treated malignancy or increased risk of leukemia; 8. Serious suspicion of psychosocial dwarfism (emotional deprivation). 9. Expected non-compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the effect of doubling the GH dose from 1 to26 mg\m2\day versus continuation of treatment with 1 mg GH\m2\day on final height, at onset of puberty in short SGA children who start puberty at a height above 140 cm; 2. To determine the dose-response effect of 1 versus 2 mg GH \m2\day in combination with LHRH analogue treatment for 2 years on final height in short SGA children who start puberty at a height below 140 cm; 3. To determine before and during long-term growth hormone treatment: a. Insulin sensitivity; b. Body composition. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of GH treatment by studying the short- and long-term effects on: a. Blood pressure; b. Thyroid function; c. Fasting glucose and insulin and HbA1c levels. | — |
Contacts
Public ContactAnnemieke J. Lem
P.O. 23068
Outcome results
None listed