Premature Infant Exposure to Noise Generated by Respiratory Support
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.
Premature Birth of Newborn
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||Premature Infant Exposure to Noise Generated by Respiratory Support|
- 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
|Study Start Date:||November 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Infants received nasal CPAP as standard of care.
High Flow Nasal Cannual
Infants received high flow nasal cannula as standard of care.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748214
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Joshua Attridge, MD||UVA School of Medicine|