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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hGH, ZOMACTON® (somatropin) | Active Comparator | For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection |
|
| No human growth hormone | No Intervention | No growth hormone is given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human growth hormone,ZOMACTON® (somatropin) | Drug | 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. |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dror Mandel, MD | Contact | +97236925690 | drorm@tlvmc.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Dror Mandel, MD | Department of Neonatology, Tel Aviv Medical Center, 64239 Tel Aviv, Israel | Principal Investigator |
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| Achenbach Child Behavior Checklist (CBCL) |
| at the end of study after 1 year of treatment |
| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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