Silicone Earplugs for VLBW Newborns in Intensive Care

Postnatal Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565357
• Other study ID #: R01-HD042639-01A3
• Status: Completed
• Phase: N/A
• First received: November 27, 2007
• Last updated: November 27, 2007
• Start date: June 2002
• Est. completion date: August 2005

Study information

• Verified date: November 2007
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Postnatal Growth

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		34 weeks post-menstrual age
Secondary	Length of stay in neonatal intensive care		hospital discharge
Secondary	Time on mechanical ventilator		hospital discharge
Secondary	Weight		18 - 22 months of age
Secondary	Length		18 - 22 months of age
Secondary	Frontal-occipital circumference		18 - 22 months of age
Secondary	Bayley Mental Developmental Index		18 - 22 months of age
Secondary	Bayley Psychomotor Developmental Index		18 - 22 months of age
Secondary	ABR Hearing Screen		hospital discharge