Research Project
9907499
The aural stimulation of the hospitalized infant in the neonatal intensive care unit (NICU) from alarms, ventilators, phones, conversations, and air handling system is linked to a myriad of problems, both acute and long-term. The stress resulting from the noise has a negative effect on vital signs, weight gain, and quality of sleep in the short term and in the long term with hearing loss and language deficit. Efforts to reduce sound levels in the NICU such as staff education have not been reported in the literature to be successful. A non-contact means of attenuating sound pressure levels for vulnerable infants in the NICU should reduce these harmful nosocomial effects. A prototype active noise control (ANC) system for use in an incubator has been developed that simultaneously permits parental or clinician voices to be passed through to the infant within. This voice pass-through feature is essential to ensure proper vocal development. Successful deployment of this incubator-based ANC system would address the clinical problems associated with excess noise while not causing a problem due to lack of adult words and conversation turns. This Phase I work is a preliminary study to ensure that the ANC system was able to attenuate recorded NICU noises and will determine if a Phase II clinical outcome study is warranted and will improve the likelihood of a successful clinical study. Upon a successful completion of Phase I, a Phase II study would seek to demonstrate the clinical efficacy under actual conditions with patients. The demonstration of clinical efficacy is necessary for a successful commercial launch. The proposed Phase I research is designed to determine whether a novel ANC system can attenuate sound in an incubator when exposed to simulated NICU sounds. While a prototype system has been developed that can attenuate sine wave signals, it will be necessary to validate that the ANC system can work effectively with simulated NICU noise from recordings in a controlled environment. The noises will include sounds found in a NICU environment including alarms, ventilator sounds, conversation, telephone rings, overhead announcements, and other factors.
