NCT00365092

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
Last Updated

August 17, 2006

Status Verified

August 1, 2006

First QC Date

August 15, 2006

Last Update Submit

August 15, 2006

Conditions

Otitis MediaMiddle Ear Effusion

Keywords

Insertion of tympanostomy tubesOtitis media with effusionChild developmentLiteracyAttentionMiddle-ear effusionEducational statusBehaviorSocial behaviorAchievement

Outcome Measures

Primary Outcomes (16)

  • All measures at 9 to 11 years of age:

  • Woodcock Reading Mastery Tests-Revised-Normative Update

  • Number of words in a grade-level passage read correctly in one minute

  • Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery

  • Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery

  • Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing

  • Children's version of the Hearing in Noise Test

  • Disruptive Behavior Disorders Rating Scale

  • Child Behavior Checklist, parent report

  • Child Behavior Checklist, teacher report

  • Impairment Rating Scales, parent report

  • Impairment Rating Scales, teacher report

  • Computerized visual continuous performance test

  • Computerized auditory continuous performance test

  • Wechsler Abbreviated Scale of Intelligence

  • Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery

Interventions

Insertion of tympanostomy tubesPROCEDURE

Eligibility Criteria

Age0 Years - 61 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (6)

  • Paradise JL, Campbell TF, Dollaghan CA, Feldman HM, Bernard BS, Colborn DK, Rockette HE, Janosky JE, Pitcairn DL, Kurs-Lasky M, Sabo DL, Smith CG. Developmental outcomes after early or delayed insertion of tympanostomy tubes. N Engl J Med. 2005 Aug 11;353(6):576-86. doi: 10.1056/NEJMoa050406.

    PMID: 16093466BACKGROUND

  • Paradise JL, Dollaghan CA, Campbell TF, Feldman HM, Bernard BS, Colborn DK, Rockette HE, Janosky JE, Pitcairn DL, Kurs-Lasky M, Sabo DL, Smith CG. Otitis media and tympanostomy tube insertion during the first three years of life: developmental outcomes at the age of four years. Pediatrics. 2003 Aug;112(2):265-77. doi: 10.1542/peds.112.2.265.

    PMID: 12897272BACKGROUND

  • Paradise JL, Feldman HM, Campbell TF, Dollaghan CA, Colborn DK, Bernard BS, Rockette HE, Janosky JE, Pitcairn DL, Sabo DL, Kurs-Lasky M, Smith CG. Early versus delayed insertion of tympanostomy tubes for persistent otitis media: developmental outcomes at the age of three years in relation to prerandomization illness patterns and hearing levels. Pediatr Infect Dis J. 2003 Apr;22(4):309-14. doi: 10.1097/01.inf.0000059764.77704.55.

    PMID: 12690269BACKGROUND

  • Paradise JL, Feldman HM, Campbell TF, Dollaghan CA, Colborn DK, Bernard BS, Rockette HE, Janosky JE, Pitcairn DL, Sabo DL, Kurs-Lasky M, Smith CG. Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years. N Engl J Med. 2001 Apr 19;344(16):1179-87. doi: 10.1056/NEJM200104193441601.

    PMID: 11309632BACKGROUND

  • MacKeith S, Mulvaney CA, Galbraith K, Webster KE, Connolly R, Paing A, Marom T, Daniel M, Venekamp RP, Rovers MM, Schilder AG. Ventilation tubes (grommets) for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Nov 15;11(11):CD015215. doi: 10.1002/14651858.CD015215.pub2.

    PMID: 37965944DERIVED

  • Paradise JL, Feldman HM, Campbell TF, Dollaghan CA, Rockette HE, Pitcairn DL, Smith CG, Colborn DK, Bernard BS, Kurs-Lasky M, Janosky JE, Sabo DL, O'Connor RE, Pelham WE Jr. Tympanostomy tubes and developmental outcomes at 9 to 11 years of age. N Engl J Med. 2007 Jan 18;356(3):248-61. doi: 10.1056/NEJMoa062980.

    PMID: 17229952DERIVED

MeSH Terms

Conditions

Otitis MediaOtitis Media with EffusionLiteracyBehaviorSocial Behavior

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic DiseasesCommunication

Study Officials

  • Jack L Paradise, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 17, 2006

Study Start

April 1, 2002

Study Completion

March 1, 2005

Last Updated

August 17, 2006

Record last verified: 2006-08

Locations

US(1)