Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-02 @ 10:49 AM
Study NCT ID:
NCT00565357
Status:
COMPLETED
Last Update Posted:
2007-11-29
First Post:
2007-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Silicone Earplugs for VLBW Newborns in Intensive Care
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Organization:
Study Overview
Official Title:
Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: