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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Human growth hormone,ZOMACTON® (somatropin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symmetrical small for gestational age at birth: weight + length+ head circumference below -2 SD for gestational age. Birth weight of 1200-2200 gr Follow-up of growth until age of 6-12 months Growth parameters below -2 SD at age of 6-12 months and absence of sufficient catch-up. Low growth hormone levels. Exclusion Criteria: Chromosomal aberration Any congenital syndrome and any syndrome that shows a tendency to uncontrolled cell growth and to develop tumors Major congenital malformation (affecting growth or development) Congenital infection Exposure to teratogenic drugs or drugs affecting development during pregnancy Maternal drug or alcohol abuse. Maternal cancer as well as cancer in 1st degree relatives.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hGH, ZOMACTON® (somatropin)<br>For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection | Drug: Human growth hormone,ZOMACTON® (somatropin)<br>* 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.<br>|
| No Intervention: No human growth hormone<br>No growth hormone is given. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III) | using the Bayley Scales of Infant Development (BSID-III) | Before treatment and 1 year later | 
| Changes in Neurological status (formal neurological examination) | using formal neurological examination | Before treatment and 1 year later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in X-ray of the hand and wrist |  | Before treatment and 1 year later | 
| Pediatric Quality of life Inventory: the PedsQL measure |  | after 1 year of treatment | 
| Achenbach Child Behavior Checklist (CBCL) |  | at the end of study after 1 year of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small for gestational age (SGA), Human growth hormone (hGH)