Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.