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

ISRCTN	ISRCTN96883876
DOI	https://doi.org/10.1186/ISRCTN96883876
Protocol serial number	NTR444
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Novo Nordisk (The Netherlands)

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

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
Email	r.h.willemsen@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Growth hormone
Primary outcome measure(s)	To assess the efficacy of biosynthetic GH treatment on various auxological parameters and bone maturation in comparison with a randomised untreated control group.
Key secondary outcome measure(s)	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
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	7 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.