An observational study in Premature Birth of Newborn, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 7 Days and older. Per ClinicalTrials.gov, last updated 2012-12-12.
Sponsored by University of Virginia · Observational
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 28 is below the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Infants born \< 32 weeks, in an incubator, and > 7 days postnatal admitted to the Newborn Intensive Care Unit
Exclusion Criteria:
Infants received nasal CPAP as standard of care.
Infants received high flow nasal cannula as standard of care.
Noise level
Noise levels will be measured during a set time while infants are on Nasal CPAP and Nasal High flow cannula as standard of care
Time frame: 6 days
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Virginia