Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11

Completed · Not applicable

Conditions studied: Otitis Media, Middle Ear Effusion

In brief

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 rapid development, concern has existed that sustained periods of middle-ear disease might cause lasting impairments of learning, speech development, language development, or behavior and social adjustment. Earlier phases of this research found that the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear disease did not affect their development at 3, 4, or 6 years of age. This study examines the children's literacy, attention, and related abilities at 9 to 11 years of age.

Key facts

Study ID

NCT00365092

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

400

Starts

2002-04-01

Expected to finish

2005-03-01

Last updated by the study team

2006-08-17

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, less than 62 days of age at enrollment

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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