Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae (hGH)
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|ClinicalTrials.gov Identifier: NCT02326610|
Recruitment Status : Not yet recruiting
First Posted : December 29, 2014
Last Update Posted : December 29, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Infant, Small for Gestational Age Growth Hormone Treatment Infant, Premature, Diseases||Drug: Human growth hormone,ZOMACTON® (somatropin)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early hGH Treatment of Symmetrically Born Small for Gestational Age Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Active Comparator: hGH, ZOMACTON® (somatropin)
For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection
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.
No Intervention: No human growth hormone
No growth hormone is given.
- Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III) [ Time Frame: Before treatment and 1 year later ]using the Bayley Scales of Infant Development (BSID-III)
- Changes in Neurological status (formal neurological examination) [ Time Frame: Before treatment and 1 year later ]using formal neurological examination
- Changes in X-ray of the hand and wrist [ Time Frame: Before treatment and 1 year later ]
- Pediatric Quality of life Inventory: the PedsQL measure [ Time Frame: after 1 year of treatment ]
- Achenbach Child Behavior Checklist (CBCL) [ Time Frame: at the end of study after 1 year of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326610
|Contact: Dror Mandel, MDfirstname.lastname@example.org|
|Principal Investigator:||Dror Mandel, MD||Department of Neonatology, Tel Aviv Medical Center, 64239 Tel Aviv, Israel|