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Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

Last updated on March 14, 2019

Study Location
Pfizer Investigational Site
Chemnitz, , 09009 Germany
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Therapy, Very Low Birth Weight Infant
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4-10 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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

- 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

- Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12+/- 3
months observation period before screening).

- Premature born defined as

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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 SDS (Hermanussen and Cole, 2003)

- length and/or body weight retardations adjusted to gestational age at birth (Lawrence et al., 1989, Voigt et al., 1996)

- children with chronological age > = 4 years and

- growth velocity

- 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.

Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age


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