Chronic Kidney Disease, Chronic Renal Insufficiency, Delivery Systems, Foetal Growth Problem, Genetic Disorder, Growth Hormone Deficiency in Children, Growth Hormone Disorder, Small for Gestational Age, Turner Syndrome
Conditions
Brief summary
This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.
Interventions
Daily administration by subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
* Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate GH treatment prior to enrollment into the study * Subjects who receive Norditropin NordiFlex® according to the SPC
Exclusion criteria
* Known or suspected allergy to study product(s) or related products * Child and/or parent unable to give consent or fill out the questionnaires * The receipt of any investigational medicinal product within 3 months prior to this study * Suffer from a life-threatening disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Usability of growth hormone injection device assessed by a quantitative scale | after 3 months of growth hormone treatment |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events | from 0 - 3 months of growth hormone treatment |
| Number of technical complaints | from 0 to 3 months of growth hormone treatment |
Countries
France
Outcome results
None listed