Silicone Earplugs for VLBW Newborns in Intensive Care

November 27, 2007 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E
Device: Silicone Earplugs
Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first
No Intervention: C
Other: Control
Standard care in the neonatal intensive care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 34 weeks post-menstrual age
34 weeks post-menstrual age

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of stay in neonatal intensive care
Time Frame: hospital discharge
hospital discharge
Time on mechanical ventilator
Time Frame: hospital discharge
hospital discharge
Weight
Time Frame: 18 - 22 months of age
18 - 22 months of age
Length
Time Frame: 18 - 22 months of age
18 - 22 months of age
Frontal-occipital circumference
Time Frame: 18 - 22 months of age
18 - 22 months of age
Bayley Mental Developmental Index
Time Frame: 18 - 22 months of age
18 - 22 months of age
Bayley Psychomotor Developmental Index
Time Frame: 18 - 22 months of age
18 - 22 months of age
ABR Hearing Screen
Time Frame: hospital discharge
hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Robert E Lasky, PhD, University of Texas Medical School at Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (Estimate)

November 29, 2007

Study Record Updates

Last Update Posted (Estimate)

November 29, 2007

Last Update Submitted That Met QC Criteria

November 27, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01HD042639-01A3 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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