Brain development after prenatal growth retardation; effects of growth hormone treatment.

Prof Dr HA Delemarre- van de Waal0 个研究点目标入组 110 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•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.

发起方

Prof Dr HA Delemarre- van de Waal