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Completed

NCT Number: NCT00565357

Silicone Earplugs for VLBW Newborns in Intensive Care

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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Key information

Conditions

Postnatal Growth

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silicone Earplugs

Device

Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first

Control

Other

Standard care in the neonatal intensive care unit

Primary outcomes

  1. Weight

    Time frame: 34 weeks post-menstrual age

Secondary outcomes

  1. Length of stay in neonatal intensive care

    Time frame: hospital discharge

  2. Time on mechanical ventilator

    Time frame: hospital discharge

  3. Weight

    Time frame: 18 - 22 months of age

  4. Length

    Time frame: 18 - 22 months of age

  5. Frontal-occipital circumference

    Time frame: 18 - 22 months of age

  6. Bayley Mental Developmental Index

    Time frame: 18 - 22 months of age

  7. Bayley Psychomotor Developmental Index

    Time frame: 18 - 22 months of age

  8. ABR Hearing Screen

    Time frame: hospital discharge

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Registry information

Official study title

Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial

Important dates

Study start
2002
Study completion
2005
First posted
Nov 29, 2007
Registry last updated
Nov 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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