Brain development after prenatal growth retardation; effects of growth hormone treatment.
- Conditions
- Study populations:group A/B: small for gestational age (sga), children without complete catch up growth with and without growth hormone treatmentgroup C: sga with complete catch up growth group D:. Children born with a normal birth weight/length and a normal postnatal growth.
- Registration Number
- NL-OMON29167
- Lead Sponsor
- Prof Dr HA Delemarre- van de Waal
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 110
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 ).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To determine the effect of prenatal growth retardation on brain functioning / development;<br>2. to determine the effect of growth hormone treatment on brain functioning / development in children born after prenatal growth retardation;<br>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
Name Time Method