Status:
COMPLETED
Follow-up to Adult Height of a Cohort of Subjects Born Small for the Gestational Age and Treated With Growth Hormone
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck, S.L., Spain
Conditions:
Infant, Small for Gestational Age
Eligibility:
All Genders
Brief Summary
This non-interventional study for prospective follow up of a cohort of 220 subjects born small for gestational age (SGA) is planned for the purpose of finding out if normalisation of adult height is a...
Detailed Description
The small for gestational age (SGA) concept includes babies born to term whose weight and/or height is lower than two standard deviations (SD) below the mean. Pathologically short stature is understoo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT01196156
Start Date
September 30 2005
End Date
December 31 2018
Last Update
February 27 2019
Active Locations (28)
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1
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
2
Hospital General de Alicante
Alicante, Spain
3
Hospital Nostra Senyora de Meritxell
Andorra, Spain
4
Hospital San Agustin
Avilés, Spain