Growth Hormone Treatment of Children after Intrauterine Growth Retardation.|
|- candidate number||1654|
|- NTR Number||NTR444|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||14-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Growth Hormone Treatment of Children after Intrauterine Growth Retardation.|
|- Scientific Title||Growth Hormone Treatment of Children after Intrauterine Growth Retardation.|
|- ACRONYM||IUGR-2 Study|
|- Healt Condition(s) or Problem(s) studied||Small for gestational age (SGA), Children with persistent short stature |
|- Inclusion criteria||1. Birth weight < P3 for gestational age (according to Usher and Mc Lean);|
2. Neonatal period without signs of severe asphyxia (defined as Apgar score < 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 ³ 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: 3.00 - 7.99 years (boys and girls);
6. Prepubertal signs defined as Tanner stage 1 or testicular volume < 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);
6. Active malignancy or increased risk of leukaemia;
7. Serious suspicion of psychosocial dwarfism (emotional deprivation);
8. Previous anabolic sex steroid or GH therapy.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-dec-1996|
|- planned closingdate||31-dec-2014|
|- Target number of participants||170|
|- Interventions||Growth hormone treatment.|
|- Primary outcome||To assess the efficacy of biosynthetic GH treatment on various auxological parameters and bone maturation in comparison with a randomized untreated control group.|
|- Secondary outcome||1. To assess the effects of biosynthetic GH treatment on bone density, lean body mass and daily food intake in comparison with a randomized untreated control group;|
2. To assess the long term efficacy of biosynthetic GH treatment on final height and other various auxological parameters;
3. To assess the safety of GH treatment by studying the short- and long-term effects on blood pressure, carbohydrate metabolism, thyroid function.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. P.E. Breukhoven|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A.C.S. Hokken-Koelega|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|Novo Nordisk Farma B.V. |
|- Publications||-Arends NJ, W VdL, Robben SG, Hokken-Koelega AC 2002 MRI findings of the pituitary gland in short children born small for gestational age (SGA) in comparison with growth hormone-deficient (GHD) children and children with normal stature. Clin Endocrinol (Oxf) 57:719-24|
-Arends N, Johnston L, Hokken-Koelega A, et al. 2002 Polymorphism in the IGF-I gene: clinical relevance for short children born small for gestational age (SGA). J Clin Endocrinol Metab 87:2720
-Arends NJ, Boonstra VH, Mulder PG, et al. 2003 GH treatment and its effect on bone mineral density, bone maturation and growth in short children born small for gestational age: 3-year results of a randomized, controlled GH trial. Clin Endocrinol (Oxf) 59:779-87
-Boonstra V, van Pareren Y, Mulder P, Hokken-Koelega A 2003 Puberty in growth hormone-treated children born small for gestational age (SGA). J Clin Endocrinol Metab 88:5753-8
-Arends NJ, Boonstra VH, Hokken-Koelega AC 2004 Head circumference and body proportions before and during growth hormone treatment in short children who were born small for gestational age. Pediatrics 114:683-90
-Boonstra VH, Mulder PG, de Jong FH, Hokken-Koelega AC 2004 Serum dehydroepiandrosterone sulfate levels and pubarche in short children born small for gestational age before and during growth hormone treatment. J Clin Endocrinol Metab 89:712-7
--Arends NJ, Boonstra VH, Duivenvoorden HJ, Hofman PL, Cutfield WS, Hokken-Koelega AC 2005 Reduced insulin sensitivity and the presence of cardiovascular risk factors in short prepubertal children born small for gestational age (SGA). Clin Endocrinol (Oxf) 62:44-50
-Hokken-Koelega A, van Pareren Y, Arends N, Boonstra V. 2004 Efficacy and safety of long-term continuous growth hormone treatment of children born small for gestational age.
Horm Res. 62 Suppl 3:149-54. Review.
-Hokken-Koelega AC, De Waal WJ, Sas TC, Van Pareren Y, Arends NJ. Small for gestational age (SGA): endocrine and metabolic consequences and effects of growth hormone treatment. 2004
J Pediatr Endocrinol Metab. Mar;17 Suppl 3:463-9.
-Hokken-Koelega AC, van Pareren Y, Sas T, Arends N. 2003 Final height data, body composition and glucose metabolism in growth hormone-treated short children born small for gestational age.Horm Res. ;60 Suppl 3:113-4.
|- Brief summary||Study evaluating the effects of GH-therapy versus no GH therapy in children with short stature born after intrauterine growth retardation (IUGR) (age 3.00 tot 7.99 years). |
Randomisation of 120 children to one of the study groups after stratification for age and parental height.
During 3 years 2/3 of the children (n = 80) will be treated with biosynthetic growth hormone, 3 IU/m2/day (GH-group), and 1/3 of the children (n = 40) will not receive growth hormone therapy (control group).
Children with GHD (max GH peak < 20 mU/L during two GH stimulation tests) will not be randomised but will receive GH therapy from the start of the study (as a separate GHD group).
After 3 years the children of the control group will also start with GH therapy, 3 IU/m2/day. GH therapy will be continued in all groups until attainment of final height.
In 1999 a group of 30 older IUGR children (age > 8 years) was added to the original protocol.
|- Main changes (audit trail)|
|- RECORD||14-sep-2005 - 14-nov-2008|
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