Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Condition: Growth Hormone Therapy; Infant, Very Low Birth Weight
MeSH terms: Birth Weight
Intervention: Somatropin; Control Arm
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 4 Years
Maximum age: 10 Years
Healthy volunteers: No

Summary:

      Safety and efficacy of Somatropin will be evaluated in short children born with a list weight
      below 1500 g and that did not catch up to normal height at the age of 4.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all of the following inclusion criteria to be eligible for enrollment
        into the trial:

          -  Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9
             years of age.

          -  Girls: Tanner stage 1 breast development

          -  Boys: Testis volume <= 3ml

          -  Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on
             growth velocity, insulin sensitivity and body composition).

          -  (In case of any signs or symptoms of gonadal puberty a GnRH-Test must decide if the
             subject is still pubertal.)

          -  Height <=-2 SD for chronological age (Brandt/Reinken).

          -  Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12+/- 3
             months observation period before screening).

          -  Premature born defined as <=1500 g birth weight.

          -  GH sufficiency (GH level > 7 ug/l following any routine GH stimulation test).

          -  Written informed consent of both parents (legal guardians) and oral/written consent of
             subject due to age specific information.

        Exclusion Criteria:

        Subjects presenting with any of the following will not be included in the trial:

          -  Other endocrine diseases except for well substituted hypothyroidism.

          -  Severe chronic diseases or medication that might influence linear growth or insulin
             sensitivity (e.g. Glucocorticoids).

          -  Positive GAD and IA-2 antibodies (for type 1 diabetes).

          -  History of malignancy

          -  Children who meet all of the following 4 criteria:

          -  actual body height < -2,5 SDS (Brandt/Reinken) and parent adjusted target height < -1
             SDS (Hermanussen and Cole, 2003)

          -  length and/or body weight retardations adjusted to gestational age at birth < -2,0 SDS
             (Lawrence et al., 1989, Voigt et al., 1996)

          -  children with chronological age > = 4 years and

          -  growth velocity < 0 SDS during the last year before inclusion.

          -  Chromosomal aberrations or syndromes.

          -  Suspected non-compliance or impossibility to follow the two or three year treatment
             schedule, respectively (e.g. social implications).

          -  Severe hemiparesis and severe CNS defects

          -  Retinopathia > third degree or laser treatment as newborns.

          -  Participation in any other clinical trial during active treatment phase.

          -  Other severe acute or chronic medical or psychiatric condition or clinically relevant
             laboratory abnormality that may increase the risk associated with trial participation
             or investigational product administration or may interfere with the interpretation of
             trial results and, in the judgement of the investigator, would make the subject
             inappropriate for entry into this trial.