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NCT01256229 · ClinicalTrials.gov registry record · Phase 1
Outcomes In Children With Developmental Delay And Deafness
A Phase 1 study of Hearing Loss and Deafness, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 303
- Enrollment target
- 2
- Study locations
NCT01256229 is a Phase 1 study of Hearing Loss and Deafness that has completed, run by Stanford University. The registered enrollment target is 303 participants, below the 6,116-participant average among 58 other Hearing Loss trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01256229, a Phase 1 study of Hearing Loss and Deafness, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 303 participants
- Enrollment target
- 2
- Study locations
Study Summary
Children with special needs require complex, individualized therapy to maximize their long-term quality of life. One subset of children with special needs includes those with both developmental delays and deafness. Currently, there is little compelling evidence supporting the idea that cochlear implantation provides benefit to children that don't have the cognitive potential to develop normal speech and language. We will perform a prospective, randomized clinical trial to answer the question of which intervention provides more benefit to this population of children using validated, norm-referenced tests. Our long-term goal is to develop guidelines that may help when selecting a treatment for hearing loss in a child with developmental delays. This proposal is significant because children with special needs are deserving of evidence upon which to base treatment decision-making, but remain under-represented in the medical literature and are often not studied. This research is designed to meet the criteria for the National Institutes of Health road map because it will generate this type of objective evidence that can directly improve patient care.
Conditions Studied
Interventions
- DEVICE hearing aids
- DEVICE cochlear implantation
Study Locations (2)
California
- Stanford University School of Medicine - Stanford
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2009-09 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01256229
The ClinicalTrials.gov registry entry for NCT01256229 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 303 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,116-participant average among 58 other Hearing Loss trials with a reported enrollment target (95% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hearing Loss appearing as the primary indexed condition, and to 2 interventions - of which hearing aids is the first listed.
NCT01256229 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Texas.
Frequently Asked Questions
What is clinical trial NCT01256229 about?
NCT01256229 is a clinical study titled "Outcomes In Children With Developmental Delay And Deafness". Children with special needs require complex, individualized therapy to maximize their long-term quality of life. One subset of children with special needs includes those with both developmental delays and deafness. Currently, there is little compelling evidence supporting the idea that cochlear impl...
What is the current status of trial NCT01256229?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 303 participants. The study started on 2009-09. Estimated completion is 2016-09.
What conditions does trial NCT01256229 study?
This clinical trial studies the following conditions: Hearing Loss, Deafness.
What interventions are being tested in trial NCT01256229?
The interventions under investigation include: hearing aids (DEVICE), cochlear implantation (DEVICE).
Who is sponsoring clinical trial NCT01256229?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01256229 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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