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The purpose of this study was to determine the effects of individual noise reduction using silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and development. The study hypothesis was that newborns who were randomized to the earplug group would be heavier than controls at 34 weeks post-menstrual age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E | Experimental |
| |
| C | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone Earplugs | Device | Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | 34 weeks post-menstrual age |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay in neonatal intensive care | hospital discharge | |
| Time on mechanical ventilator | hospital discharge | |
| Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert E Lasky, PhD | University of Texas Medical School at Houston | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19194455 | Derived | 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. |
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| Control | Other | Standard care in the neonatal intensive care unit |
|
| 18 - 22 months of age |
| Length | 18 - 22 months of age |
| Frontal-occipital circumference | 18 - 22 months of age |
| Bayley Mental Developmental Index | 18 - 22 months of age |
| Bayley Psychomotor Developmental Index | 18 - 22 months of age |
| ABR Hearing Screen | hospital discharge |