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NCT00365092 · ClinicalTrials.gov registry record · NA

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

A NA study of Otitis Media and Middle Ear Effusion, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
NA
Development phase
400
Enrollment target
1
Study location

NCT00365092 is a NA study of Otitis Media and Middle Ear Effusion that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 400 participants, below the 4,315-participant average among 14 other Otitis Media trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00365092, a NA study of Otitis Media and Middle Ear Effusion, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
NA
Development phase
400 participants
Enrollment target
1
Study location

Study 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 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.

Interventions

  • PROCEDURE Insertion of tympanostomy tubes

Study Locations (1)

Pennsylvania

  • Children's Hospital of Pittsburgh - Pittsburgh

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2002-04
Est. Completion 2005-03
Phase NA

What the Registry Record Tells You About NCT00365092

The ClinicalTrials.gov registry entry for NCT00365092 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,315-participant average among 14 other Otitis Media trials with a reported enrollment target (91% lower). The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Otitis Media appearing as the primary indexed condition, and to 1 intervention - of which Insertion of tympanostomy tubes is the first listed.

NCT00365092 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00365092 about?

NCT00365092 is a clinical study titled "Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11". 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 last...

What is the current status of trial NCT00365092?

This trial is currently completed. It is a NA study. The enrollment target is 400 participants. The study started on 2002-04. Estimated completion is 2005-03.

What conditions does trial NCT00365092 study?

This clinical trial studies the following conditions: Otitis Media, Middle Ear Effusion.

What interventions are being tested in trial NCT00365092?

The interventions under investigation include: Insertion of tympanostomy tubes (PROCEDURE).

Who is sponsoring clinical trial NCT00365092?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00365092 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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