title: A randomized clinical trial evaluating silicone earplugs for very low birth weight newborns in intensive care.
abstract: 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.
authors.affiliation: Pediatric Group of Acadiana, New Iberia, LA, USA.
authors.forename: C
authors.initials: C
authors.lastname: Abou Turk
authors.forename: A L
authors.initials: AL
authors.lastname: Williams
authors.forename: R E
authors.initials: RE
authors.lastname: Lasky
mesh_terms: 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*
chemical_list: D012828:Silicones