Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-28 @ 10:41 PM
Study NCT ID:
NCT01367834
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2011-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014424', 'term': 'Turner Syndrome'}], 'ancestors': [{'id': 'D006059', 'term': 'Gonadal Dysgenesis'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D058533', 'term': 'Sex Chromosome Disorders of Sex Development'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rebecca_knickmeyer@med.unc.edu', 'phone': '9199662216', 'title': 'Rebecca Knickmeyer Santelli', 'organization': 'UNC Chapel Hill'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Low scan success rate and subject drop out resulted in small sample size (5 GH treated, 1 control).'}}, 'adverseEventsModule': {'timeFrame': 'Baseline and 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Growth Hormone', 'description': 'Subjects in the somatotropin (growth hormone, GH) arm will receive GH injections from 12-24 months of life.\n\nsomatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Subjects will receive no GH or placebo.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Brain Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.'}, {'id': 'OG001', 'title': 'Control', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '18.22', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '19.78', 'spread': 'NA', 'comment': 'N of 1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in total brain volume as determined by magnetic resonance imaging (MRI)', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).'}, {'type': 'SECONDARY', 'title': 'Volume of Brain Lobes (Occipital)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.'}, {'id': 'OG001', 'title': 'Control', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '14.83', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '12.16', 'spread': 'NA', 'comment': 'N = 1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of occipital lobes as determined by MRI.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).'}, {'type': 'SECONDARY', 'title': 'White Matter Tracts (SLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.'}, {'id': 'OG001', 'title': 'Control', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '15.12', 'spread': '5.01', 'groupId': 'OG000'}, {'value': '16.35', 'spread': 'NA', 'comment': 'N = 1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in FA from 12 months of age scan in 24 months of age scan', 'description': 'Change in the fractional anisotropy (FA) of white matter tracts using Diffusion Tensor Imaging (DTI); superior longitudinal fasciculus', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).'}, {'type': 'SECONDARY', 'title': 'Volume of Brain Lobes (Central)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.'}, {'id': 'OG001', 'title': 'Control', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '17.63', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '10.23', 'spread': 'NA', 'comment': 'N = 1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of central brain region (precentral gyrus, postcentral gyrus, rolandic operculum) as determined by MRI.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).'}, {'type': 'SECONDARY', 'title': 'Volume of Brain Lobes (Frontal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.'}, {'id': 'OG001', 'title': 'Control', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '15.43', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '14.38', 'spread': 'NA', 'comment': 'N = 1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of frontal lobes as determined by MRI.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).'}, {'type': 'SECONDARY', 'title': 'Volume of Brain Lobes (Temporal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.'}, {'id': 'OG001', 'title': 'Control', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '10.79', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '5.08', 'spread': 'NA', 'comment': 'N = 1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of temporal lobes as determined by MRI.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).'}, {'type': 'SECONDARY', 'title': 'Volume of Brain Lobes (Parietal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.'}, {'id': 'OG001', 'title': 'Control', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '18.86', 'spread': '5.01', 'groupId': 'OG000'}, {'value': '11.95', 'spread': 'NA', 'comment': 'N = 1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of parietal lobes as determined by MRI.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).'}, {'type': 'SECONDARY', 'title': 'Volume of Brain Lobes (Limbic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.'}, {'id': 'OG001', 'title': 'Control', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '15.43', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '22.71', 'spread': 'NA', 'comment': 'N = 1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of parietal lobes as determined by MRI.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).'}, {'type': 'SECONDARY', 'title': 'Volume of Brain Lobes (Insular Cortex)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.'}, {'id': 'OG001', 'title': 'Control', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '15.79', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '19.78', 'spread': 'NA', 'comment': 'N = 1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of parietal lobes as determined by MRI.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.\n\nsomatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Subjects will receive no GH or placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Study was ended.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited locally in the UNC\\_Chapel Hill pediatric endocrinology clinic and nationally through the Turner Syndrome Society, Turner Syndrome family internet groups, and advertisements on our UNC research website.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Growth Hormone', 'description': 'Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.\n\nsomatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Subjects will receive no GH or placebo.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.12', 'spread': '0.82', 'groupId': 'BG000'}, {'value': '12.73', 'spread': '0.50', 'groupId': 'BG001'}, {'value': '12.96', 'spread': '0.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2011-06-02', 'resultsFirstSubmitDate': '2016-12-12', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-03', 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Brain Volume', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in total brain volume as determined by magnetic resonance imaging (MRI)'}], 'secondaryOutcomes': [{'measure': 'Volume of Brain Lobes (Occipital)', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of occipital lobes as determined by MRI.'}, {'measure': 'White Matter Tracts (SLF)', 'timeFrame': 'Change in FA from 12 months of age scan in 24 months of age scan', 'description': 'Change in the fractional anisotropy (FA) of white matter tracts using Diffusion Tensor Imaging (DTI); superior longitudinal fasciculus'}, {'measure': 'Volume of Brain Lobes (Central)', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of central brain region (precentral gyrus, postcentral gyrus, rolandic operculum) as determined by MRI.'}, {'measure': 'Volume of Brain Lobes (Frontal)', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of frontal lobes as determined by MRI.'}, {'measure': 'Volume of Brain Lobes (Temporal)', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of temporal lobes as determined by MRI.'}, {'measure': 'Volume of Brain Lobes (Parietal)', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of parietal lobes as determined by MRI.'}, {'measure': 'Volume of Brain Lobes (Limbic)', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of parietal lobes as determined by MRI.'}, {'measure': 'Volume of Brain Lobes (Insular Cortex)', 'timeFrame': 'Change in volume from 12 months of age scan in 24 months of age scan', 'description': 'Percent change in volumes of parietal lobes as determined by MRI.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Turner Syndrome', 'growth hormone', 'brain development'], 'conditions': ['Turner Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Studies in older children and adults have found that IQ (intelligence quotient) in individuals with Turner syndrome (TS) and the general population are similar. However, many individuals with TS have a nonverbal learning disability which may cause problems with imagining and working with objects in space (for example: building blocks, working puzzles, copying designs, driving a car) as well as problems in planning, paying attention, and getting along with people their own age. Studies of brain structure have found changes in the size and function of specific areas of the brain that are involved in these nonverbal processes. However, there are no data published on brain structure or function in girls with Turner Syndrome in the first few years of life when brains are learning and growing most rapidly.\n\nIn a recent study, very young, short girls with Turner Syndrome (TS)(averaging 2 years in age) were treated with Growth Hormone (GH) and almost reached an average height after 2 years. The risks of GH for the young girls in that study appeared to be the same as those for older girls. Therefore, it is now recommended that GH therapy be considered as soon as a child with TS has growth failure. Growth failure often occurs during infancy; therefore, more children with TS are now receiving GH therapy as young as 12 months of age. In this study, the investigators wish to start understanding what effect GH has on learning and brain growth when given between the ages of 12 and 24 months. In this study, the girls with TS will have developmental studies, a physical examination, magnetic resonance imaging (MRI), and blood drawn at one and two years of age. Some of the girls in this study will receive GH from 12 until 24 months of life, while others will not. Brain growth and development will be compared between those who have been treated with GH and those who have not. This is a pilot study in which the investigators will gather data to design a larger study that can answer these questions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '13 Months', 'minimumAge': '11 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Turner syndrome\n* Less than the 50th percentile for length for the general female population\n\nExclusion Criteria:\n\n* Prior Growth Hormone (GH) therapy\n* Diabetes\n* Allergy to metacresol (a preservative in the GH liquid that is injected)\n* Contraindications for Magnetic Resonance Imaging (MRI) (such as metal in the body)\n* Part of a Y chromosome in child's karyotype\n* 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)\n* Parent/guardian is not willing for child to have some of her developmental testing digitally recorded for scoring"}, 'identificationModule': {'nctId': 'NCT01367834', 'briefTitle': 'Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome', 'orgStudyIdInfo': {'id': '09-2171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Growth Hormone', 'description': 'Subjects in the somatotropin (growth hormone, GH) arm will receive GH injections from 12-24 months of life.', 'interventionNames': ['Drug: somatotropin']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects will receive no GH or placebo.'}], 'interventions': [{'name': 'somatotropin', 'type': 'DRUG', 'otherNames': ['Genotropin', 'Growth hormone'], 'description': 'Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life.', 'armGroupLabels': ['Growth Hormone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Rebecca Knickmeyer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rebecca Knickmeyer Santelli, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rebecca Knickmeyer Santelli, PhD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}