Infant, Premature, Diseases Clinical Trial
Official title:
Early hGH Treatment of Symmetrically Born Small for Gestational Age Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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