Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT01196156
Eligibility Criteria:
Inclusion Criteria:
* Children with growth disorder (current height \<-2.5 SD and height adjusted to parental stature \<-1 SD) in children born SGA with a weight and/or length at birth below -2 SD, that has not experimented a growth catch-up (growth speed \<0 SD during the last year) at 4 years old or afterwards were enrolled in the study
* Children undergoing treatment with somatropin from Serono
* Children whose parent or legal guardians, as well as the subject himself if 12 or more years old have given written permission to access their records
Exclusion Criteria:
* Children with closed epiphysis
* Children with known hypersensitivity to somatropin or to any excipients present in the injection powder or solvent
* Subjects with active neoplasms. Any anti-tumoral treatment must be completed prior to starting treatment with somatropin
* Subjects with evidence of progression or relapse of a subjacent intracranial lesion
* Subjects with acute critical diseases such as those that present complications after open heart surgery, abdominal surgery, polytraumatisms, acute respiratory failure or similar conditions
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01196156
Study Brief:
Protocol Section:
NCT01196156