Silicone Earplugs for VLBW Newborns in Intensive Care

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00565357
First received: November 27, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 27, 2007
November 27, 2007
June 2002
Not Provided
Weight [ Time Frame: 34 weeks post-menstrual age ]
Same as current
No Changes Posted
  • Length of stay in neonatal intensive care [ Time Frame: hospital discharge ]
  • Time on mechanical ventilator [ Time Frame: hospital discharge ]
  • Weight [ Time Frame: 18 - 22 months of age ]
  • Length [ Time Frame: 18 - 22 months of age ]
  • Frontal-occipital circumference [ Time Frame: 18 - 22 months of age ]
  • Bayley Mental Developmental Index [ Time Frame: 18 - 22 months of age ]
  • Bayley Psychomotor Developmental Index [ Time Frame: 18 - 22 months of age ]
  • ABR Hearing Screen [ Time Frame: hospital discharge ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Postnatal Growth
  • 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
  • Experimental: E
    Intervention: Device: Silicone Earplugs
  • No Intervention: C
    Intervention: Other: Control
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. Epub 2009 Feb 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
August 2005
Not Provided

Inclusion Criteria:

  • birthweight between 401 and 1500 grams
  • less than 1 week of age
  • parental informed consent
  • availability of research personnel

Exclusion Criteria:

  • terminal illness
  • congenital anomalies
  • syndromes associated with hearing loss
Both
up to 7 Days
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00565357
R01-HD042639-01A3
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Robert E Lasky, PhD University of Texas Medical School at Houston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP