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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR865 |
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Date of registration:
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05/01/2007 |
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Primary sponsor: |
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Public title:
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Brain development after prenatal growth retardation; effects of growth hormone treatment.
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Scientific title:
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Brain development after prenatal growth retardation; effects of growth hormone treatment.
- sga brain development study |
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Date of first enrolment:
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1/3/2007 |
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Target sample size:
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110 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=865 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: Single; Control: Not applicable; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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H.M.A.
Bie, de |
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Address:
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VU Medisch Centrum,
Kinderendocrinologie , Postbus 7057
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+ 31 20-4440895 |
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Email:
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b.debie@vumc.nl |
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Affiliation:
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Name:
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H.M.A.
Bie, de |
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Address:
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VU Medisch Centrum,
Kinderendocrinologie , Postbus 7057
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+ 31 20-4440895 |
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Email:
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b.debie@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria group A/B:
1.Birth weight or birth length below ?2 SD adjusted for duration of pregnancy;
2. Present height below ?2.5 SD and at least 1 SD below target height-SDS;
3. Calendar age between 4 and 6 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 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 -SDS.
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 (TH ± 1SD ).
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 <3 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 GHD;
5. Medications or interventions during the previous 6 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, LHRH analogue;
7. Active or treated malignancy or increased risk of leukemia;
8. Serious suspicion of psychosocial dwarfism (emotional deprivation);
9. Severe neurological disability;
10. Expected non-compliance;
11. Prematurity < 35 weeks;
12. For MEG/MRI investigation: Treatment with irremovable metal wires.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Small for gestational age (SGA), Brain development
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Intervention(s)
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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 6 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.
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Primary Outcome(s)
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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.
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Secondary ID(s)
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ISRCTN20279720
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N/A
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Source(s) of Monetary Support
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VU University Medical Center, Department of Pediatric Endocrinology
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