A Randomized Clinical Trial Evaluating Silicone Earplugs for Very Low Birth Weight Newborns in Intensive Care

OBJECTIVE: Determine whether very low birth weight (VLBW) newborns (<1500 g) wearing silicone earplugs grow larger and perform better on developmental exams than controls. STUDY DESIGN: 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 18−22 months. RESULT: 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 6 controls on the Bayley Mental Development Index. Their head circumferences were 2.59 cms (95% CI: 0.97, 4.21) larger. CONCLUSION: Earplugs may facilitate weight gain in VLBW newborns. Better outcomes may persist at 18−22 months at least in ELBW infants.