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

NCT00140413 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-04-01

Study results available
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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.

Conditions

  • Growth Hormone Deficiency
  • Septo-Optic Dysplasia
  • Hypopituitarism

Interventions

DRUG

Nutropin AQ

Daily injection. Dosage dependent on weight.

Sponsors & Collaborators

Principal Investigators

  • Mark Borchert, MD · Childrens Hospital Los Angeles; University of Southern California

  • Mitchell Geffner, MD · Children's Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00140413 on ClinicalTrials.gov