NCT01643057

Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Wyss Institute at Harvard University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore physiological interventions and biomarkers for Apnea of Prematurity in newborn infants.

Detailed description

Apnea of prematurity is defined as cessation of breathing that lasts for more than 20 seconds and/or is accompanied by oxygen desaturation or a decrease in heart rate (bradycardia). Because apnea presents itself within a variety of diseases in newborns, its diagnosis is based largely on the exclusion of other findings. The difficulty in relating the manifestation of apnea to its cause can lead to issues regarding appropriate medical management and delays in treatment. Our exploration of physiological interventions for Apnea of Prematurity begins with stochastic resonance. Stochastic resonance is the introduction of noise to a system, to alter the system's behavior. This technology has been examined in previous medical applications. The hypothesis for this work is that stochastic resonance stimulation, in the form of gentle vibrations, will stabilize immature breathing patterns in infants. In this research study, we will use an apnea mattress developed by engineers at the Wyss Institute, Harvard University, which provides gentle vibrations to the infant. We will closely follow the research protocol from UMass Medical School. Whilst the infant is on the mattress, clinical care data will be collected to determine effect on breathing patterns. We also hope to collect enough baseline and intervention data signals to be able to identify candidate biomarkers for apnea. This will assist in development of predictive algorithms for apnea in infants.

Conditions

• Apnea of Prematurity

Interventions

Type	Name	Description
DEVICE	Stochastic Resonance Mattress	The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available, designed by engineers at the Wyss Institute, Harvard University) to provide gentle vibrations and sounds during mattress stimulations.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-07-17
• Last updated: 2015-09-10

Locations

1 site across 1 country: United States