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

Journal of Perinatology volume 29, pages 358–363 (2009)Cite this article

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.

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Acknowledgements

None of the authors had any arrangement with any company whose products are mentioned in this paper. This study was supported by the National Institute of Child Health and Human Development (NICHD R01 HD042639). We would like to thank the nursing staff at the Children's Memorial Hermann Neonatal Intensive Care Unit for their cooperation and support. This clinical trial has been listed on ClinicalTrials.gov (NCT00565357). The NICHD award supplied salary support for Amber L Williams and Robert E Lasky.

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Authors and Affiliations

  1. Pediatric Group of Acadiana, New Iberia, LA, USA

    C Abou Turk

  2. University of Texas Medical School at Houston, Center for Clinical Research and Evidence-Based Medicine, Houston, TX, USA

    A L Williams & R E Lasky

Authors
  1. C Abou Turk
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  2. A L Williams
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  3. R E Lasky
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Correspondence to R E Lasky.

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Abou Turk, C., Williams, A. & Lasky, R. A randomized clinical trial evaluating silicone earplugs for very low birth weight newborns in intensive care. J Perinatol 29, 358–363 (2009). https://doi.org/10.1038/jp.2008.236

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  • DOI: https://doi.org/10.1038/jp.2008.236

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