N/A
Completed N=17
Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome
Source: ClinicalTrials.gov NCT01367834 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Total Brain Volume — 18.22; 19.78 percentage change
Summary
The purpose of this research study is to learn about brain development in very young girls with Turner syndrome (TS) and the effect that growth hormone (GH) therapy has on early brain development.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Brain Volume |
18.22; 19.78 | — |
| SECONDARY Volume of Brain Lobes (Occipital) |
14.83; 12.16 | — |
| SECONDARY White Matter Tracts (SLF) |
15.12; 16.35 | — |
| SECONDARY Volume of Brain Lobes (Central) |
17.63; 10.23 | — |
| SECONDARY Volume of Brain Lobes (Frontal) |
15.43; 14.38 | — |
| SECONDARY Volume of Brain Lobes (Temporal) |
10.79; 5.08 | — |
| SECONDARY Volume of Brain Lobes (Parietal) |
18.86; 11.95 | — |
| SECONDARY Volume of Brain Lobes (Limbic) |
15.43; 22.71 | — |
| SECONDARY Volume of Brain Lobes (Insular Cortex) |
15.79; 19.78 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Turner syndrome
- Less than the 50th percentile for length for the general female population
Exclusion Criteria
- Prior Growth Hormone (GH) therapy
- Diabetes
- Allergy to metacresol (a preservative in the GH liquid that is injected)
- Contraindications for Magnetic Resonance Imaging (MRI) (such as metal in the body)
- Part of a Y chromosome in child's karyotype
- Parent/guardian is not willing for child to be randomized to be in the treatment group (receives Growth Hormone injections for one year) or the control group (receives no Growth Hormone during the study)
- Parent/guardian is not willing for child to have some of her developmental testing digitally recorded for scoring
Data sourced from ClinicalTrials.gov (NCT01367834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.