Growth hormone treatment of children after IntraUterine Growth Retardation: IUGR-2 study

Not Applicable

Completed

• Conditions: Small for gestational age (SGA) children with persistent short stature; Pregnancy and Childbirth; Slow foetal growth and foetal malnutrition

• Registration Number: ISRCTN96883876
• Lead Sponsor: Erasmus Medical Centre (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Birth weight less than P3 for gestational age (according to Usher and McLean)
2. Neonatal period without signs of severe asphyxia (defined by Apgar score less than 3 after 5 minutes), without signs of chronic lung disease (such as bronchopulmonary dysplasia)
3. No catch-up growth defined as obtaining a height of P3 within the first 2 years of life or at a later stage
4. Height velocity (cm/year) for chronological age P50
5. Chronological age at the start of treatment: 3.0 - 7.99 years (boys and girls)
6. Prepubertal signs defined as Tanner stage 1 or testicular volume less than 4 ml
7. Well documented growth data from birth up to 2 years and at least 1 year before the start of the study

Exclusion Criteria

1. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism or inborn errors of metabolism, except of GHD
2. Disorders of genito-urinary tract, cardiopulmonary or gastrointestinal tract, or nervous systems, nutritional and/or vitamin deficiencies
3. Chromosomal abnormalities or signs of a syndrome, except of Silver-Russell Syndrome (SRS)
4. Chondrodysplasia
5. Hydrocephalus
6. Active malignancy or increased risk of leukaemia
7. Serious suspicion of psychosocial dwarfism (emotional deprivation)
8. Previous anabolic sex steroid or GH therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified