Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-01-31

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.

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Detailed Description

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Conditions

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Foetal Growth Problem Small for Gestational Age

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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somatropin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children treated for 3 years with Maxomat® because of small for gestational age
* Postnatal growth failure by the age of 3 years or more
* No associated growth hormone deficiency
* Height growth velocity greater than 2 cm/yr over the 12 month period preceding the inclusion
* Bone age no more than 13 years for girls and no more than 15 years for boys

Exclusion Criteria

* Known, evolving tumour
* Hypertrophic cardiomyopathy
* Hypertension not controlled on maximum therapy
* Benign intracranial hypertension
* Known glucose intolerance or known diabetes mellitus
* Acute or active chronic hepatitis
* Chronic renal failure
* Chromosomal and/or genetic syndromes (other than Silver-Russell syndrome) or abnormality

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No