A randomized clinical trial evaluating silicone earplugs for very low birth weight newborns in intensive care

C Abou Turk, A L Williams, R E Lasky, C Abou Turk, A L Williams, R E Lasky

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.

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 to 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 six controls on the Bayley Mental Development Index. Their head circumferences were 2.59 cm (95% CI: 0.97, 4.21) larger.

Conclusion: Earplugs may facilitate weight gain in VLBW newborns. Better outcomes may persist at 18 to 22 months at least in ELBW infants.

Trial registration: ClinicalTrials.gov NCT00565357.

Figures

Figure 1
Figure 1
Flowchart of participants from randomization to follow-up assessment
Figure 2
Figure 2
The 23 NICU Nurses’ Responses to the Short-Answer Study Survey Questions

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