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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
  Purpose

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.


Condition Intervention
Postnatal Growth
 Device: Silicone Earplugs
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Noise
U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Weight [ Time Frame: 34 weeks post-menstrual age ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: June 2002
Study Completion Date: August 2005
Arms Assigned Interventions
Experimental: E Device: Silicone Earplugs
Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first
No Intervention: C Other: Control
Standard care in the neonatal intensive care unit

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565357

Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Robert E Lasky, PhD University of Texas Medical School at Houston
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00565357     History of Changes
Other Study ID Numbers: R01-HD042639-01A3
Study First Received: November 27, 2007
Last Updated: November 27, 2007
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Postnatal Growth
Postnatal Development
Noise
Neonatal Intensive Care Unit

ClinicalTrials.gov processed this record on May 16, 2013