Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
16/03/2007
Prospective/Retrospective
Prospectively 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 H M A de Bie

ORCID ID

Contact details

VU Medisch Centrum
Kinderendocrinologie
Amsterdam
1007 MB
Netherlands
+ 31 (0)20 444 0895
b.debie@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SGA Brain Development study

Study hypothesis

This study aims to evaluate the effect of growth hormone treatment on brain functioning and development in children born with a low birth weight/length with incomplete catch up growth.

The two other hypotheses this study aims to evaluate are:
1. Is there a difference in brain functioning in children born with a low birth weight/length between those without and with complete catch up growth?
2. Will intra-uterine growth failure affect brain development/functioning?

Ethics approval

Approval received from the Medical Ethics Review Committee of de Vrije Universiteit medical centre, Amsterdam on the 1st March 2007 (ref: 06/279).

Study design

Non-randomised parallel group trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Small for Gestational Age (SGA), brain development

Intervention

Structural (only at baseline) and functional MRI’s, MEG and extensive neuropsychologic testing will be performed at baseline, after one year and three years in both groups A (treatment with growth hormone (somatropin) and B (without treatment).

SGA patients older than six years of age, with incomplete catch-up growth with the indication of GH treatment, will be followed on neuropsychologic functioning.

Hypothesis 2/ 3:
In groups C and D structural and functional MRI’s, MEG and extensive neuropsychological testing will be performed only at start of the study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. To determine the effect of prenatal growth retardation on brain functioning/development
2. To determine the effect of growth hormone treatment on brain functioning/development in children born after prenatal growth retardation
3. To assess wether there is a difference in brain development in between SGA children with and without postnatal catch up growth

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/03/2007

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria group A/B:
1. Birth weight or birth length below -2 Standard Deviation (SD) adjusted for duration of pregnancy
2. Present height below -2.5 SD and at least 1 SD below target height-SD score
3. Calendar age between four and six years
4. No evidence of catch up growth during the preceding year
5. Children are under regular control by pediatrician, choose to be or not to be treated with Growth Hormone (GH)

Inclusion criteria group C:
1. Birth weight or birth length below -2 SD adjusted for duration of pregnancy
2. Present height above -2.0 SD and above minus 1 SD of target height -SD score

Inclusion criteria group D:
1. Normal birth weight/length adjusted for duration of pregnancy
2. Present height above -2 SD for age and within target range (Target Height [TH] ± 1 SD)

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

110

Participant exclusion criteria

1. Known syndromes and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described, except for Silver Russell Syndrome
2. Severe asphyxia (defined as Apgar score less than three after 5 minutes), and no serious diseases such as long-term artificial ventilation and oxygen supply, bronchopulmonary dysplasia or other chronic lung disease
3. Coeliac disease and other chronic or serious diseases of the gastrointestinal tract, heart, genito-urinary tract, liver, lungs, skeleton or central nervous system, or chronic or recurrent major infectious diseases, nutritional and/or vitamin deficiencies
4. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism, except of Growth Hormone Deficiency (GHD)
5. Medications or interventions during the previous six months that might have interfered with growth, such as corticosteroids (including high dose of corticosteroid inhalation), sex steroids, growth hormone, or major surgery (particularly of the spine or extremities)
6. Use of medication that might interfere with growth during GH therapy, such as corticosteroids, sex steroids, Luteinising Hormone-Releasing Hormone (LHRH) analogue
7. Active or treated malignancy or increased risk of leukaemia
8. Serious suspicion of psychosocial dwarfism (emotional deprivation)
9. Severe neurological disability
10. Expected non-compliance
11. Prematurity less than 35 weeks
12. For Magnetoencephalography (MEG)/Magnetic Resonance Imaging (MRI) investigation: treatment with irremovable metal wires

Recruitment start date

01/03/2007

Recruitment end date

01/03/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU Medisch Centrum
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

Pfizer B.V. (The Netherlands)

Sponsor details

P.O. Box 37
Capelle a/d IJssel
2900 AA
Netherlands

Sponsor type

Industry

Website

http://www.pfizer.nl

Funders

Funder type

Hospital/treatment centre

Funder name

VU University Medical Centre (VUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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