Clinical trial NCT00625872: Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
Official title: Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Growth Hormone Therapy
Infant, Small for Gestational Age
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-28
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
measure: Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
measure: Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
measure: Change From Baseline in Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) at Months 6, 12 and 18
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; One-leg-jump) at Months 6, 12 and 18
timeFrame: Baseline, Month 6 , Month 12 and Month 18
measure: Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; One-leg-jump) at Months 6, 12 and 18
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Change From Baseline in Maximum Jump Velocity (Vmax; One-leg-jump) at Months 6, 12 and 18
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Five-chair Rising Test-Peak Jump Power (PJP) at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
measure: Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
measure: Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
measure: Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
measure: Change From Baseline in One-chair Rising Test-Peak Jump Power (PJP) at Months 6, 12 and 18
timeFrame: Baseline, Month 6 , Month 12 and Month 18
measure: Change From Baseline in One-chair Rising Test-Peak Jump Force (PJF) at Months 6, 12 and 18
timeFrame: Baseline, Month 6 , Month 12 and Month 18
measure: Change From Baseline in One-chair Rising Test (Time to Perform the Tasks) at Months 6, 12 and 18
timeFrame: Baseline, Month 6 , Month 12 and Month 18
measure: Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
measure: Mean Upper Arm Circumference
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Mean Thigh Circumference
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Mean Calf Circumference
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Mean Height at Month 6
timeFrame: Month 6
measure: Mean Height at Months 12 and 18
timeFrame: Month 12 and Month 18
measure: Mean Growth Velocity at Month 6
timeFrame: Month 6
measure: Mean Growth Velocity at Months 12 and 18
timeFrame: Month 12 and Month 18
measure: Mean Height-Standard Deviation Score (SDS) at Month 6
timeFrame: Month 6
measure: Mean Height-Standard Deviation Score (SDS) at Months 12 and 18
timeFrame: Month 12 and Month 18
measure: Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6
timeFrame: Month 6
measure: Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18
timeFrame: Month 12 and Month 18
measure: Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
measure: Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
measure: Sitting Height-Standard Deviation Score (SDS)
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Body Mass Index-Standard Deviation Score (BMI-SDS)
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Change From Baseline in Head Circumference at Months 6, 12 and 18
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Change From Baseline in Head Circumference-Standard Deviation Score (SDS) at Months 6, 12 and 18
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Months 12 and 18
timeFrame: Baseline, Month 12 and Month 18
Other outcomes:
measure: Change From Baseline in Bone Density Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months
timeFrame: Baseline, Month 6, Month 12 and Month 18
measure: Change From Baseline in Bone Stability Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months
timeFrame: Baseline, Month 6, Month 12 and Month 18
Locations:
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Datteln
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Kiel
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: