Growth hormone treatment of children after IntraUterine Growth Retardation: IUGR-2 study
| ISRCTN | ISRCTN96883876 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96883876 |
| Secondary identifying numbers | NTR444 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 29/12/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R.H. Willemsen
Scientific
Scientific
Erasmus Medical Center
Sophia Children's Hospital
Room number SP-3435
P.O. Box 2060
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 463 6363 |
|---|---|
| r.h.willemsen@erasmusmc.nl |
Study information
| Study design | Multicentre randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Growth hormone treatment of children after IntraUterine Growth Retardation: IUGR-2 study |
| Study acronym | IUGR-2 Study |
| Study objectives | Study evaluating the effects of growth hormone (GH)-therapy versus no GH therapy in children with short stature born after intrauterine growth retardation (IUGR) (age 3.00 tot 7.99 years). |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Small for gestational age (SGA) children with persistent short stature |
| Intervention | Growth hormone treatment versus untreated control group. For 3 years 2/3 of the children (n = 80) will be treated with biosynthetic growth hormone, 3 IU/m^2/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 less than 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/m^2/day. GH therapy will be continued in all groups until attainment of final height. In 1999 a group of 30 older IUGR children (aged greater than 8 years) was added to the original protocol. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Growth hormone |
| Primary outcome measure | To assess the efficacy of biosynthetic GH treatment on various auxological parameters and bone maturation in comparison with a randomised untreated control group. |
| Secondary outcome measures | 1. To assess the effects of biosynthetic GH treatment on bone density, lean body mass and daily food intake in comparison with a randomised 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 |
| Overall study start date | 17/12/1996 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 7 Years |
| Sex | Both |
| Target number of participants | 170 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/12/1996 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Website | http://www.erasmusmc.nl/content/englishindex.htm |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Industry
Novo Nordisk (The Netherlands)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Novo Nordisk Global
- Location
- Denmark
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2017 | Yes | No |
Editorial Notes
29/12/2016: Publication reference added.
