Silicone Earplugs for VLBW Newborns in Intensive Care

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Postnatal Growth

Treatments: Other: Control; Device: Silicone Earplugs

Study type: Interventional

Funder types: NIH

Identifiers

NCT00565357

R01HD042639-01A3

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

E

Experimental group

Treatment:

Device: Silicone Earplugs

C

No Intervention group

Treatment:

Other: Control