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Published on: January 7, 2016
Growth Hormone Dose Modulation and Final Height in Short Children Born Small for Gestational Age: French Real-Life
Régis Coutant, Bruno Leheup1, Marc Nicolino2
1Department of Clinical Genetics and Infant Medicine, Medical School and University Hospital of the University of Lorraine, Nancy, France.
Insights
Growth hormone (GH) therapy helps short children born small for gestational age (SGA) achieve better height outcomes. Long-term studies show it is fairly effective with no new safety concerns identified.
Area of Science:
- Pediatrics
- Endocrinology
- Growth Disorders
Background:
- Growth hormone (GH) therapy is used for children born small for gestational age (SGA).
- Limited real-world data exist on long-term GH exposure and outcomes in this population.
- Observational studies are crucial for understanding long-term treatment effects.
Purpose of the Study:
- To evaluate the long-term effectiveness of GH therapy in children born SGA.
- To identify factors associated with achieving normal adult height.
- To assess the safety profile of extended GH treatment.
Main Methods:
- An observational study (NCT01578135) followed children born SGA treated with GH for over 5 years.
- Primary endpoints included height standard deviation score (SDS) at last visit and final adult height (FAH) SDS.
- Multivariate logistic regression identified factors influencing GH dose and height achievement.
Main Results:
- 66.3% of children achieved normal height SDS at the last visit; 24.7% reached FAH.
- Factors for normal height SDS included better baseline height SDS, younger age at start, longer treatment duration, and no chronic disease.
- Most adverse events were non-serious, with no new safety concerns.
Conclusions:
- GH therapy demonstrates fair effectiveness in improving height outcomes for short children born SGA.
- Long-term GH treatment in this cohort was associated with acceptable safety.
- Further real-world data support the use of GH in managing SGA-related short stature.
Introduction:
Growth hormone (GH) therapy improves height outcomes in short children born small for gestational age (SGA); however, real-world data on long-term GH exposure are few.
Methods:
We report results from an observational study (NCT01578135) including children born SGA, treated with GH at 126 sites in France, and followed up for >5 years until achieving final adult height (FAH) or until study termination. Primary endpoints were the proportion of patients with normal (>-2) height standard deviation score (SDS) at the last visit and with normal FAH SDS. Post hoc analyses were performed by multivariate logistic regression analysis with stepwise elimination to identify factors associated with GH dose modulation and normal height SDS achievement.
Results:
Of 1,408 registered patients, a representative sample (n = 291) was selected for long-term follow-up. At the last visit, 193/291 (66.3%) children achieved normal height SDS and 72/291 (24.7%) reached FAH. FAH SDS was >-2 for chronological age in 48 (66.7%) children and >-2 for adult age in 40 (55.6%) children. In the post hoc analyses, height SDS at the last visit was a significant determinant of whether GH dose had been modulated. Factors significantly associated with reaching normal height SDS were baseline height SDS (taller, better), age at treatment start (younger, better), treatment duration excluding discontinuation periods (longer, better), and absence of a chronic disease. Most (70%) adverse events were non-serious, with 39% considered possibly/probably related to GH treatment.
Conclusions:
GH therapy was fairly effective in most short children born SGA. No new safety concerns were identified.
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