Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2010

Conditions
Growth Hormone TherapyInfant, Very Low Birth Weight
Interventions
DRUG

Somatropin

Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get the possibility to continue treatment for a further year. The study will end after 2 and 3 years of observation, respectively.

OTHER

Control Arm

Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year.

Trial Locations (8)

50937

Pfizer Investigational Site, Cologne

66424

Pfizer Investigational Site, Homburg

69120

Pfizer Investigational Site, Heidelberg

72076

Pfizer Investigational Site, Tübingen

79106

Pfizer Investigational Site, Freiburg im Breisgau

91054

Pfizer Investigational Site, Erlangen

09009

Pfizer Investigational Site, Chemnitz

04103

Pfizer Investigational Site, Leipzig

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00174460 - Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age | Biotech Hunter | Biotech Hunter