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

J Perinatol. 2009 May;29(5):358-63. doi: 10.1038/jp.2008.236. Epub 2009 Feb 5.

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Anthropometry
  • Body Mass Index
  • Child Development / physiology
  • Critical Care / methods
  • Ear Protective Devices*
  • Female
  • Follow-Up Studies
  • Humans
  • Infant, Newborn
  • Infant, Very Low Birth Weight / growth & development*
  • Intensive Care Units, Neonatal*
  • Linear Models
  • Male
  • Noise / adverse effects
  • Noise / prevention & control*
  • Probability
  • Reference Values
  • Risk Assessment
  • Sensitivity and Specificity
  • Silicones / chemistry
  • Weight Gain / physiology*

Substances

  • Silicones

Associated data

  • ClinicalTrials.gov/NCT00565357