SGA Infants who do not show a developmental catch-up growth within the first 6 months of life fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in partial hGH/IGF-I deficiency. Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I deficiency in SGA children can be the major or contributory cause of to their neurodevelopmental deficits To assess the effect of early growth hormone treatment given to symmetrical small for gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and growth between birth and 6-12 months. The study is an innovative research not previously performed for improving neurodevelopmental outcome of SGA infants. As this is the first study of its kind, the safety of use of GH has not been reported, however based on multiple studies assessing use of GH in infants and young children, it is reasonable to similarly expect no short and long-term adverse effects. The study will take place at the Tel Aviv Medical Center only.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The initial dose will be 30µg/kg/day. The maximal dose will be 40µg/kg/day. The dose will be adjusted by monitoring the serum IGF-I level. Growth hormone will be delivered by injection.
Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III)
using the Bayley Scales of Infant Development (BSID-III)
Time frame: Before treatment and 1 year later
Changes in Neurological status (formal neurological examination)
using formal neurological examination
Time frame: Before treatment and 1 year later
Changes in X-ray of the hand and wrist
Time frame: Before treatment and 1 year later
Pediatric Quality of life Inventory: the PedsQL measure
Time frame: after 1 year of treatment
Achenbach Child Behavior Checklist (CBCL)
Time frame: at the end of study after 1 year of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.