A randomized clinical trial evaluating silicone earplugs for very low birth weight newborns in intensive care.
OBJECTIVE
To determine whether very low birth weight (VLBW) newborns (<1500 g) wearing silicone earplugs grow larger and perform better on developmental exams than controls.


METHODS
VLBW newborns (n=34) were randomized to wearing earplugs or not. Hospital outcomes were abstracted from medical charts by research staff masked to intervention status. Fourteen extremely low birth weight (ELBW) newborns (<1000 g) were also evaluated at 18 to 22 months.


RESULTS
After adjusting for birth weight, 11 surviving newborns in the earplug group were 225 g (95% CI: 45, 405) heavier at 34 weeks post menstrual age than the 13 controls. Six ELBW earplug infants scored 15.53 points (95% CI: 3.03, 28.02) higher than six controls on the Bayley Mental Development Index. Their head circumferences were 2.59 cm (95% CI: 0.97, 4.21) larger.


CONCLUSIONS
Earplugs may facilitate weight gain in VLBW newborns. Better outcomes may persist at 18 to 22 months at least in ELBW infants.
Abou Turk
C
C
Pediatric Group of Acadiana, New Iberia, LA, USA.
Williams
A L
AL
Lasky
R E
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D000886:Anthropometry; D015992:Body Mass Index; D002657:Child Development / Q000502:physiology; D003422:Critical Care / Q000379:methods; D004430:Ear Protective Devices; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight / Q000254:growth & development*; D007363:Intensive Care Units, Neonatal; D016014:Linear Models; D008297:Male; D009622:Noise / Q000009:adverse effects / Q000517:prevention & control*; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D012828:Silicones / Q000737:chemistry; D015430:Weight Gain / Q000502:physiology*
D012828:Silicones