NCT00565357

Brief Summary

The purpose of this study was to determine the effects of individual noise reduction using silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and development. The study hypothesis was that newborns who were randomized to the earplug group would be heavier than controls at 34 weeks post-menstrual age.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2002

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
Last Updated

November 29, 2007

Status Verified

November 1, 2007

First QC Date

November 27, 2007

Last Update Submit

November 27, 2007

Conditions

Postnatal Growth

Keywords

Postnatal GrowthPostnatal DevelopmentNoiseNeonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Weight

    34 weeks post-menstrual age

Secondary Outcomes (8)

  • Length of stay in neonatal intensive care

    hospital discharge

  • Time on mechanical ventilator

    hospital discharge

  • Weight

    18 - 22 months of age

  • Length

    18 - 22 months of age

  • Frontal-occipital circumference

    18 - 22 months of age

  • +3 more secondary outcomes

Study Arms (2)

E

EXPERIMENTAL
Device: Silicone Earplugs

C

NO INTERVENTION
Other: Control

Interventions

Silicone EarplugsDEVICE

Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first

E
ControlOTHER

Standard care in the neonatal intensive care unit

C

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • birthweight between 401 and 1500 grams
  • less than 1 week of age
  • parental informed consent
  • availability of research personnel

You may not qualify if:

  • terminal illness
  • congenital anomalies
  • syndromes associated with hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Abou Turk C, Williams AL, Lasky RE. 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.

    PMID: 19194455DERIVED

Study Officials

  • Robert E Lasky, PhD

    University of Texas Medical School at Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 29, 2007

Study Start

June 1, 2002

Study Completion

August 1, 2005

Last Updated

November 29, 2007

Record last verified: 2007-11