An observational study in Stress and Sleep, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 1 Week to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-03-13.
Sponsored by Weill Medical College of Cornell University · Observational
This project is being done in order to determine if the music of Mozart will have a soothing effect on premature infants while in the neonatal intensive care unit (NICU). The primary effect to be anticipated will be a reduction in heart rate from baseline, decreased motor activity from baseline, as well as an increase of time in which the babies are in quiet sleep states while the music is being played.
Upon admission, all infants in the NICU are placed on monitors that continuously track their heart rate, respiratory rate, and oxygen saturation. During our study, data will be collected from the monitors already in use. Total time of observation will be approximately 3 hours. In addition, a monitoring device called an Actiwatch will also be used. This device looks similar to a traditional wristwatch and will be loosely strapped to the ankle or wrist of each infant using a foam and velcro strap. This device continuously monitors the baby's movements allowing us to determine if there is a change in the baby's activity level while the music is being played. It will record the baby's activity prior to the start of the music and will continue until 30 minutes after the music has stopped.
The music of Mozart will be played using a small speaker in the baby's isolette. The volume of the music will be set at 10 decibels over background noise, which on previous measurement has been found to be approximately 55 decibels (about the same as a running refrigerator or as the sound of rainfall; 60 decibels is the volume of normal conversation). The volume in the crib will be continuously monitored throughout the hour. As a final recording device, we will also intermittently be using video to capture the reactions of these infants to the music. The study will be done once a week per infant on the same day and at the same time every week
Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 163 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
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Premature infants
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Exclusion Criteria:
Stable premature infants
Behavioral: Music
The record gives a start of Jun 2005, a primary completion of Jun 2007 and a completion of Jun 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University →