Condition category
Pregnancy and Childbirth
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
14/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
r.h.willemsen@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR444

Study information

Scientific title

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

http://www.erasmusmc.nl/content/englishindex.htm

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

Publication citations

Additional files

Editorial Notes