Brain Development after prenatal growth retardation: effects of growth hormone treatment
| ISRCTN | ISRCTN20279720 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20279720 |
| Secondary identifying numbers | NL851 (NTR865) |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 26/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H M A de Bie
Scientific
Scientific
VU Medisch Centrum
Kinderendocrinologie
Amsterdam
1007 MB
Netherlands
| Phone | + 31 (0)20 444 0895 |
|---|---|
| b.debie@vumc.nl |
Study information
| Study design | Non-randomised parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Brain Development after prenatal growth retardation: effects of growth hormone treatment |
| Study acronym | SGA Brain Development study |
| Study objectives | 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(s) | Approval received from the Medical Ethics Review Committee of de Vrije Universiteit medical centre, Amsterdam on the 1st March 2007 (ref: 06/279). |
| Health condition(s) or problem(s) studied | Small for Gestational Age (SGA), brain development |
| Intervention | Structural (only at baseline) and functional MRIs, 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 MRIs, MEG and extensive neuropsychological testing will be performed only at start of the study. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/03/2007 |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 6 Years |
| Sex | Not Specified |
| Target number of participants | 110 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU Medisch Centrum
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
Pfizer B.V. (The Netherlands)
Industry
Industry
P.O. Box 37
Capelle a/d IJssel
2900 AA
Netherlands
| Website | http://www.pfizer.nl |
|---|---|
"ROR" |
https://ror.org/02bzf1224 |
Funders
Funder type
Hospital/treatment centre
VU University Medical Centre (VUMC) (The Netherlands)
No information available
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 |
Editorial Notes
26/08/2021: Proactive update review. No publications found. Search options exhausted.
