Growth Hormone Treatment, Infant, Premature, Diseases, Infant, Small for Gestational Age
Conditions
Keywords
Small for gestational age (SGA), Human growth hormone (hGH)
Brief 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.
Interventions
DRUGHuman 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.
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III) | Before treatment and 1 year later | using the Bayley Scales of Infant Development (BSID-III) |
| Changes in Neurological status (formal neurological examination) | Before treatment and 1 year later | using formal neurological examination |
Secondary
| Measure | 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 |
Contacts
Primary ContactDror Mandel, MD
Outcome results
None listed