Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy (SGA-POWER)

Pfizer

Status and phase

Terminated

Phase 3

Conditions

Infant, Small for Gestational Age

Growth Hormone Therapy

Treatments

Drug: Somatropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00625872

A6281283

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

6 to 10 years old

Volunteers

No Healthy Volunteers

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.