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Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

Last updated on May 11, 2018

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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.
Show details

- 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.
Show details

- 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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Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Growth Hormone Therapy
  • Infant, Small for Gestational Age
Drug: Somatropin
Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
  • Active Comparator: Treatment Group
    Somatropin for 12 months
    Intervention: Drug: Somatropin
  • Control Group
    In the first 6 months no intervention, afterwards Somatropin for 12 months
    Intervention: Drug: Somatropin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
March 2011
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00625872
A6281283
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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