Trials / Completed
CompletedNCT00565357
Silicone Earplugs for VLBW Newborns in Intensive Care
Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
- Sex
- All
- Age
- 7 Days
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Silicone Earplugs | Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first |
| OTHER | Control | Standard care in the neonatal intensive care unit |
Timeline
- Start date
- 2002-06-01
- Completion
- 2005-08-01
- First posted
- 2007-11-29
- Last updated
- 2007-11-29
Source: ClinicalTrials.gov record NCT00565357. Inclusion in this directory is not an endorsement.