Brain Development after prenatal growth retardation: effects of growth hormone treatment

Pfizer B.V. (The Netherlands)0 sites110 target enrollmentFebruary 26, 2007

Overview

No summary available.

Registry

who.int

Start Date

February 26, 2007

End Date

March 1, 2011

Last Updated

4 years ago

Study Type

Interventional

Sponsor

Pfizer B.V. (The Netherlands)

•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\. 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