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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
34
Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first
Standard care in the neonatal intensive care unit
Weight
Time frame: 34 weeks post-menstrual age
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
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