Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Growth Hormone Therapy Infant, Very Low Birth Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

Group Type ACTIVE_COMPARATOR

Somatropin

Intervention Type DRUG

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.

Control Arm

Intervention Type OTHER

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.

Control Arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No