Music's Effects on Premature Babies.

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00224211
First received: September 20, 2005
Last updated: March 12, 2008
Last verified: September 2005
  Purpose

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


Condition Intervention
Stress
Sleep
Behavioral: Music

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Homophonic Sounds on Preterm Infants

Further study details as provided by Weill Medical College of Cornell University:

Enrollment: 50
Study Start Date: June 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
I
Stable premature infants
Behavioral: Music

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Premature infants

Criteria

Inclusion Criteria:

  • All infants born at 28 weeks gestation or who are at least 28 weeks corrected age are eligible to participate. Only those in isolettes (incubators) will be included. Once a baby has been transitioned to a bassinet or crib, the baby will be pulled from the study. In order to be included, these infants must be in stable condition (without serious active medical issues) as decided by their doctor and must be breathing without the use of a ventilator.

Exclusion Criteria:

  • Exclusion criteria will include a history of intraventricular hemorrhage involving the white matter (as diagnosed by head ultrasound), as well as those infants born with severe congenital deformities.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224211

Locations
United States, New York
New York Presbyterian Hospital Weill Cornell
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Michelle M Meza, MD New York Presbyterian Hospital Weill Cornell
  More Information

Publications:
Responsible Party: Michelle Meza, Dept. of Newborn Medicine
ClinicalTrials.gov Identifier: NCT00224211     History of Changes
Other Study ID Numbers: 0506007948
Study First Received: September 20, 2005
Last Updated: March 12, 2008
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014