Phase 4 Completed N=20 Randomized Treatment

Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia

Growth Hormone Deficiency · Septo-Optic Dysplasia · Hypopituitarism

Source: ClinicalTrials.gov NCT00140413 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcomePrimary: Change in Anthropometric Measures Over Time — 1.97; -0.61; 1.39; 1.22 Z-score

Summary

Hypotheses: 1. The prevalence of endocrinopathies, and growth hormone (GH) deficiency in particular, among young children diagnosed with optic nerve hypoplasia (ONH) is higher than is commonly thought. 2. Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes. Aims: 1. Determine the prevalence and types of endocrinopathies in children diagnosed with ONH. 2. Correlate endocrine outcome with radiographic, ocular, and developmental findings in children with ONH. 3. Examine the effect of GH treatment on growth and obesity in children with ONH, GH-deficiency, and either subnormal or normal growth compared to children with ONH that are not GH-deficient. 4. Compare growth outcomes between children with isolated GH-deficiency and those with multiple hormone deficiencies.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Anthropometric Measures Over Time	1.97; -0.61; 1.39; 1.22; -0.38; 0.58	—

Eligibility Criteria

Inclusion Criteria

New subjects diagnosed with ONH less than or equal to 2 years of age and subjects actively enrolled (in currently approved prospective ONH study) will be eligible for enrollment.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00140413). 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.