Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2002-06-30
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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E
Silicone Earplugs
Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first
C
Control
Standard care in the neonatal intensive care unit
Interventions
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Silicone Earplugs
Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first
Control
Standard care in the neonatal intensive care unit
Eligibility Criteria
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Inclusion Criteria
* less than 1 week of age
* parental informed consent
* availability of research personnel
Exclusion Criteria
* congenital anomalies
* syndromes associated with hearing loss
7 Days
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Principal Investigators
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Robert E Lasky, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Medical School at Houston
References
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Abou Turk C, Williams AL, Lasky RE. A randomized clinical trial evaluating silicone earplugs for very low birth weight newborns in intensive care. J Perinatol. 2009 May;29(5):358-63. doi: 10.1038/jp.2008.236. Epub 2009 Feb 5.
Other Identifiers
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