NCT02326610

Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae

Early hGH Treatment of Symmetrically Born Small for Gestational Age Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 6 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infant, Small for Gestational Age
• Growth Hormone Treatment
• Infant, Premature, Diseases

Interventions

Type	Name	Description
DRUG	Human growth hormone,ZOMACTON® (somatropin)	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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2014-12-29
• Last updated: 2014-12-29