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Sponsors and Collaborators: |
Children's Hospital Los Angeles Genentech |
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Information provided by: | Children's Hospital Los Angeles |
ClinicalTrials.gov Identifier: | NCT00140413 |
Hypotheses:
Aims:
Condition | Intervention | Phase |
---|---|---|
Growth Hormone Deficiency Septo-Optic Dysplasia Hypopituitarism |
Drug: Nutropin AQ |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia |
Estimated Enrollment: | 38 |
Study Start Date: | December 2004 |
Subjects for this study will be recruited from active and newly enrolled subjects in our larger ONH study. The study duration is two years and we anticipate 38 subjects will enroll. Subjects will be recruited for this study if they present with either growth deceleration or at least one subnormal result for IGF-1 or IGFBP-3.
Baseline information collected includes: height, weight, head circumference, examinations by an endocrinologist and ophthalmologist, endocrine laboratory testing, fundus photography, electrophysiology testing, head MRI, and a developmental assessment. A glucagon stimulation test will be performed and subjects who are deemed GH-deficient and who have delayed growth will be assigned to GH treatment, in line with standard clinical practice. Those with normal growth but determined to be GH-deficient by a glucagon stimulation test will be randomized to treatment with GH vs observation only.
Subjects randomized to treatment with GH will be provided with GH for the duration of their participation in the study. Enrolled subjects will return every four months to monitor progress. Subjects will undergo a physical examination at each visit, including height, weight, head circumference, and body fat. In addition, subjects randomized to growth hormone will have laboratory testing of thyroid, IGF-1 and IGFBP-3 hormones, and fasting lipid levels.
Ages Eligible for Study: | up to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Cassandra A Fink, MPH | 323.669.2267 | cfink@chla.usc.edu |
United States, California | |
Childrens Hospital Los Angeles | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Cassandra A Fink, MPH 323-669-2267 cfink@chla.usc.edu | |
Principal Investigator: Mark Borchert, MD |
Principal Investigator: | Mark Borchert, MD | Childrens Hospital Los Angeles; University of Southern California |
Principal Investigator: | Mitchell Geffner, MD | Children's Hospital Los Angeles |
Study ID Numbers: | 03.261 |
Study First Received: | August 31, 2005 |
Last Updated: | March 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00140413 |
Health Authority: | United States: Institutional Review Board |
Optic Nerve Hypoplasia |
Bone Diseases, Endocrine Dwarfism Hypopituitary dwarfism Nervous System Malformations Gonadal Disorders Dwarfism, Pituitary Brain Diseases Bone Diseases Sex Differentiation Disorders Urogenital Abnormalities Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental |
Congenital Abnormalities Hypothalamic Diseases Pituitary Diseases Endocrine System Diseases Central Nervous System Diseases Kallmann Syndrome Septo-optic dysplasia Growth hormone deficiency Hypogonadism Genetic Diseases, Inborn Endocrinopathy Septo-Optic Dysplasia |
Nervous System Diseases |