Postnatal Growth
Conditions
Keywords
Postnatal Growth, Postnatal Development, Noise, Neonatal Intensive Care Unit
Brief 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.
Interventions
DEVICESilicone Earplugs
Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first
OTHERControl
Standard care in the neonatal intensive care unit
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight | 34 weeks post-menstrual age |
Secondary
| Measure | Time frame |
|---|---|
| Time on mechanical ventilator | hospital discharge |
| Weight | 18 - 22 months of age |
| Length | 18 - 22 months of age |
| Length of stay in neonatal intensive care | hospital discharge |
| Bayley Mental Developmental Index | 18 - 22 months of age |
| Bayley Psychomotor Developmental Index | 18 - 22 months of age |
| ABR Hearing Screen | hospital discharge |
| Frontal-occipital circumference | 18 - 22 months of age |
Outcome results
None listed