Contact information
Type
Scientific
Primary contact
Dr R.H. Willemsen
ORCID ID
Contact details
Erasmus Medical Center
Sophia Children's Hospital
Room number SP-3435
P.O. Box 2060
Rotterdam
3015 GJ
Netherlands
+31 (0)10 463 6363
r.h.willemsen@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR444
Study information
Scientific title
Growth hormone treatment of children after IntraUterine Growth Retardation: IUGR-2 study
Acronym
IUGR-2 Study
Study hypothesis
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
Received from the local medical ethics committee
Study design
Multicentre randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Growth hormone
Primary outcome measures
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 trial start date
17/12/1996
Overall trial end date
31/12/2014
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
170
Participant 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
Recruitment start date
17/12/1996
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Novo Nordisk (The Netherlands)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Denmark
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/28011067