Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

Condition(s) targeted: Growth Hormone Therapy; Infant, Small for Gestational Age

Intervention: Somatropin (Drug); Somatropin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome: Changes in peak jump power (PJP), peak jump force (PJF) and maximal jump velocity (Vmax) after six months (two-leg-jump; Leonardo jump plate)(hierarchic testing)

Secondary outcome:

Intellectual performance test battery for assessment of neurocognitive function in children

Changes in peak jump power (PJP), peak jump force (PJF) and maximal jump velocity (Vmax)(one-leg-jump; Leonardo jump plate)

Improvement in chair rising test (one/five stand up test)

Changes in maximal isometric grip force using hand grip dynamometer

Changes in bone density, bone structure and bone stability using pqCT (in selected centers only, where pqCT belongs to clinical standard)

Upper arm, thigh and calf circumferences

Height (cm) and growth velocity (cm/yr)

Height SDS and growth velocity SDS for chronological age

Change of height SDS and growth velocity SDS for chronological age

Sitting height SDS

Body mass index (SDS)

Change in head circumference (cm)

Change in head circumference (SDS)

Changes in body composition (skinfold thickness SDS)

Standard diagnostic procedures (blood samples) to control the safety of GH-therapy

Minimum age: 6 Years. Maximum age: 10 Years. Gender(s): Both.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Koeln 50937, Germany; Recruiting

Pfizer Investigational Site, Tuebingen 72076, Germany; Not yet recruiting

Pfizer Investigational Site, Erlangen 91054, Germany; Recruiting

Pfizer Investigational Site, Muenchen 80337, Germany; Recruiting

Pfizer Investigational Site, Heidelberg 69120, Germany; Not yet recruiting

Pfizer Investigational Site, Essen 45122, Germany; Recruiting

Pfizer Investigational Site, Magdeburg 39120, Germany; Not yet recruiting

Pfizer Investigational Site, Datteln 45711, Germany; Recruiting

Pfizer Investigational Site, Bochum 44866, Germany; Not yet recruiting

Pfizer Investigational Site, Dresden 01307, Germany; Recruiting

Pfizer Investigational Site, Kiel 24105, Germany; Recruiting

Pfizer Investigational Site, Berlin 13353, Germany; Recruiting

Pfizer Investigational Site, Freiburg 79106, Germany; Not yet recruiting

To obtain contact information for a study center near you, click here.

Starting date: July 2008
Ending date: February 2011
Last updated: September 11, 2009