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Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chemnitz, , 09009 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Therapy, Very Low Birth Weight Infant
Sex
Females and Males
Age
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.
Show details

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.
Show details

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.

NCT00174460
Pfizer
Completed
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

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Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Somatropin Therapy For Short Children Born Of Premature Gestation, A Controlled, Prospective Randomized, Multicenter Study With An Untreated Control Group.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Growth Hormone Therapy
  • Infant, Very Low Birth Weight
  • 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.
  • Active Comparator: Treatment Arm
    Interventions:
    • Drug: Somatropin
    • Other: Control Arm
  • No Intervention: Control Arm
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
March 2010
March 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
4 Years to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00174460
A6281273
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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