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

Prof Dr HA Delemarre- van de Waal0 sites110 target enrollmentTBD

Overview

Phase: Not Applicable
Intervention: Not specified
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.
Sponsor: Prof Dr HA Delemarre- van de Waal
Enrollment: 110
Status: Not yet recruiting
Last Updated: 2 years ago

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Prof Dr HA Delemarre- van de Waal

•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\. 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;