Status:
COMPLETED
Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Otitis Media
Middle Ear Effusion
Eligibility:
All Genders
Up to 61 years
Phase:
NA
Brief Summary
Middle-ear disease (infection and fluid) is the most common illness in young children after the common cold. Because hearing loss accompanies middle-ear disease, and because early life is a period of ...
Detailed Description
Concern has long existed that persistent otitis media in young children, because of the associated conductive hearing loss, can result in lasting impairments of the children's development. Accordingly...
Eligibility Criteria
Inclusion
- Healthy, less than 62 days of age at enrollment
Exclusion
- birth weight less than 5 lb (2268 g)
- small for gestational age
- history of neonatal asphyxia or other serious illness
- major congenital abnormality or chronic illness
- multiple birth
- sibling enrolled in the study
- in foster care or adopted before enrollment
- mother dead, seriously ill, a known drug or alcohol abuser before enrollment
- mother judged by study personnel to be too limited socially or intellectually to give informed consent or adhere to the study protocol
- mother less than 18 years of age
- English not the only household language
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00365092
Start Date
April 1 2002
End Date
March 1 2005
Last Update
August 17 2006
Active Locations (1)
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1
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213