Abstract

This study's main objectives are to determine whether persistent otitis media with effusion (OME) in the first 3 years of life results in lasting impairments of speech, language, cognitive, or psychosocial development, and if so, whether they are prevented or lessened by prompt tympanostomy- tube placement (TTP). From 2 hospitals and 6 pediatric practices 6391 well infants aged <2mo were enrolled. Middle-ear status and hearing are monitored. Up to age 3, children who reach specified criteria regarding persistent OME are randomized to undergo TTP either promptly or after a defined extended period of OME persists. Detailed developmental tests are administered at ages 3, 4 and 6 yr to all subjects who had met randomization criteria and to a sample of others representing a spectrum of OME experience. Analyses of results will enable determinations whether associations exist between early OME and later developmental impairments; if so, whether the associations are causal; and whether prompt TTP is effective in preventing or lessening such impairments.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000084-40
Application #
6567074
Study Section
Project Start
2001-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2002
Total Cost
Indirect Cost

  Institution

Name
Children's Hosp Pittsburgh/Upmc Health Sys
Department
Type
DUNS #
044304145
City
Pittsburgh
State
PA
Country
United States
Zip Code
15224

  Publications

Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Arslanian, Silva; El Ghormli, Laure; Kim, Joon Young et al. (2018) The Shape of the Glucose Response Curve During an Oral Glucose Tolerance Test: Forerunner of Heightened Glycemic Failure Rates and Accelerated Decline in ?-Cell Function in TODAY. Diabetes Care :
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Arslanian, Silva; El Ghormli, Laure; Bacha, Fida et al. (2017) Adiponectin, Insulin Sensitivity, ?-Cell Function, and Racial/Ethnic Disparity in Treatment Failure Rates in TODAY. Diabetes Care 40:85-93
Sereika, Susan M; Becker, Dorothy; Schmitt, Patricia et al. (2016) Operationalizing and Examining Family Planning Vigilance in Adult Women With Type 1 Diabetes. Diabetes Care 39:2197-2203
Chernausek, Steven D; Arslanian, Silva; Caprio, Sonia et al. (2016) Relationship Between Parental Diabetes and Presentation of Metabolic and Glycemic Function in Youth With Type 2 Diabetes: Baseline Findings From the TODAY Trial. Diabetes Care 39:110-7

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