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Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Berlin, , 13353 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Therapy, Small for Gestational Age Infant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-10 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 2002, Voigt et al. 2006 or Lawrence et al. 1989).

- Current height-SDS -1 (Hermanussen and Cole 2003).

- Growth velocity SDS

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Severe SGA (birth weight or length features.

- Severe pre-maturity (GA

- 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.

NCT00625872
Pfizer
Terminated
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

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