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Premature Infant Exposure to Noise Generated by Respiratory Support

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonathan Swanson, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01748214
First received: December 6, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

Infants in neonatal intensive care units are increasing exposed to non-invasive ventilatory support modes (nasal continuous positive airway pressure - NCPAP and high flow nasal cannula: >1 L/min flow - HFNC). While there have been small descriptive studies of noise exposure in infants on NCPAP, there have been no comparative trials done comparing noise exposure in infants undergoing both NCPAP and HFNC.

Objective: Using a cross-over model determine noise exposure levels in infants exposed to similar levels of respiratory support provided by NCPAP and HFNC.


Condition
Premature Birth of Newborn

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Premature Infant Exposure to Noise Generated by Respiratory Support

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Noise level [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    Noise levels will be measured during a set time while infants are on Nasal CPAP and Nasal High flow cannula as standard of care


Enrollment: 28
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Nasal CPAP
Infants received nasal CPAP as standard of care.
High Flow Nasal Cannual
Infants received high flow nasal cannula as standard of care.

Detailed Description:

Infants born < 32 weeks, in an incubator, and > 7 days postnatal that were maintained on either on NCPAP or HFNC to maintain SaO2 in a range of 88 - 92 %. Study infants had decibel measurements obtained every 15 seconds for 30 minutes using a noise dosimeter (NoisePro DLX-1). The microphone for the dosimeter was suspended from the inside of the incubator such that it hung 1 foot above the infants nose and mouth. The exhalation port for NCPAP was placed outside of the incubator. Repeated measurement periods on the same mode of support were made within a 72 hour period. Each infant the acted as their own control and was switched within 7 days to the alternative respiratory support method that maintained similar SaO2 goals and repeat measurements were obtained. Comparisons of mean decibel levels during recording were compared using paired t-tests.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infants born < 32 weeks, in an incubator, and > 7 days postnatal admitted to the Newborn Intensive Care Unit

Criteria

Inclusion Criteria:

  • Premature infant born < 32 weeks and 0 days post-conceptional age;
  • Seven or more days of age and not in acute respiratory distress;
  • Need for nasal continuous positive airway pressure or high-flow nasal cannula for ventilation or supplemental oxygen delivery;
  • In a neutral-thermal environment (i.e. isolette)

Exclusion Criteria:

  • Oro-facial congenital anomalies;
  • Congenital heart disease (except for patent ductus arteriosus and/or patent foramen ovale);
  • Unstable respiratory status as deemed by the attending physician
  • Patients under isolation for infectious disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748214

Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Joshua Attridge, MD UVA School of Medicine
  More Information

No publications provided

Responsible Party: Jonathan Swanson, MD, Prinicipal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT01748214     History of Changes
Other Study ID Numbers: 13164
Study First Received: December 6, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
continuous positive airway pressure
high flow nasal cannula
hearing outcomes
noise exposure
preterm infants

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013