Standardized versus individualized growth hormone treatment of short children born small for gestational age: Effects on short-term and long-term efficacy, long-term psychosocial development, glucose metabolism and body composition.

Phase 4

Withdrawn

Conditions: dysmaturity
small for gestational age
10052547

Registration Number: NL-OMON39333

Lead Sponsor: Stichting Kind en Groei

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

- Children born with a birth length and/or weight < -2 SDS for gestational age (Niklasson)
- Short stature defined as height SD score below *2.5 according to the Dutch National Growth References of 1997.
- Height of * 1 SD score below target height SD score (TH SDS).
- Height velocity (cm/year) for chronological age * 0 SDS in prepubertal children.
- Chronological age at start of treatment between 4 and 11 years for boys and between 4 and 9 years for girls.
- Bone age (G&P) * 13 years for girls and * 15 years for boys.
- Well documented growth data from birth up to 2 years and at least 1 year before the start of the study.
- Informed consent.

Exclusion Criteria

- Syndromes (except for Silver Russell Syndrome), chromosomal abnormalities and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described.
- severe psychomotor retardation according to DSM IV.
- Complicated neonatal period.
- Celiac disease and other chronic or serious diseases of the gastro-intestinal tract, heart, genito-urinary tract, liver, lungs, skeleton or central nervous system, or chronic or recurrent major infectious diseases, nutritional and/or vitamin deficiencies.
- Any endocrine or metabolic disorder, except for growth hormone deficiency (GHD).
- Genetic alterations in the IGF-I receptor gene.
- Medications or interventions during the previous 6 months that might have interfered with growth.
- Use of medication that might interfere with growth during growth hormone therapy.
- Active or treated malignancy or increased risk of leukaemia.
- Serious suspicion of psychosocial dwarfism (emotional deprivation).
- Expected non-compliance.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The effect of individual growth hormone therapy compared to standard treatment<br /><br>with 1 mg/m2/day, assessment of long-term safety and psychosocial development. </p><br>

Secondary Outcome Measures