Outcomes In Children With Developmental Delay And Deafness
Public ClinicalTrials.gov record NCT01256229. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
OUTCOMES IN CHILDREN WITH DEVELOPMENTAL DELAY AND DEAFNESS: A PROSPECTIVE, RANDOMIZED TRIAL
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01256229
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 303 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Day to 5 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2009
- Primary completion
- Aug 31, 2016
- Completion
- Aug 31, 2016
- Last update posted
- Nov 14, 2016
2009 – 2016
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01256229, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 14, 2016 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01256229 live on ClinicalTrials.gov.