Status:
TERMINATED
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
Lead Sponsor:
Pfizer
Conditions:
Growth Hormone Therapy
Infant, Small for Gestational Age
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
Brief Summary
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.
Eligibility Criteria
Inclusion
- Pre-pubertal boys between 6 and 10 years of age or girls between 6 and 9 years of age.
- Birth length- and/or birth weight-SDS adjusted to gestational age \< -2.0 (Voigt et al. 2002, Voigt et al. 2006 or Lawrence et al. 1989).
- Current height-SDS \< -2.5 (Brandt/Reinken 1992) and parental adjusted height-SDS below -1 (Hermanussen and Cole 2003).
- Growth velocity SDS \< 0 during the last year before inclusion (Brandt/Reinken 1988).
Exclusion
- Severe SGA (birth weight or length \< -4 SD) and clinically relevant dysmorphic features.
- Severe pre-maturity (GA \< 32 weeks of gestation).
- Severe perinatal complications like asphyxia, sepsis, necrotizing enterocolitis (NEC), respiratory distress syndrome, if associated with long-term sequelae (like short bowel syndrome, bronchopulmonary dysplasia (BPD), cerebral palsy etc).
- Inability to perform one- or two leg jumps from a standing position.
- Prior GH treatment.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00625872
Start Date
July 1 2008
End Date
March 1 2011
Last Update
February 29 2012
Active Locations (10)
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1
Pfizer Investigational Site
Berlin, Germany, 13353
2
Pfizer Investigational Site
Bonn, Germany, 53113
3
Pfizer Investigational Site
Cologne, Germany, 50937
4
Pfizer Investigational Site
Datteln, Germany, 45711