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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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

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Detailed Description

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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

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Apnea of Prematurity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Stochastic Resonance Mattress

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Eligible subjects are infants currently inpatient in the NICU at Beth Israel Deaconess Medical Center and:

* Born premature, at a gestational age \< 36 weeks
* Demonstrate irregular breathing by having had at least one documented clinical apnea (\> 20 seconds), bradycardia (\< 100 bpm) and/or desaturation (\< 90%)

* Is at a Post Conceptual Age of \> 45 weeks at time of study (Calculated as: weeks of age at birth + weeks of age since birth)
* Has demonstrable pulmonary disease at time of study, i.e. Chronic Lung Disease, Infant Respiratory Distress Syndrome
* Has Hypoxic-Ischemic Encephalopathy including a cord pH of ≤ 7
* Has a congenital abnormality
* Has a genetic syndrome
* Has an anatomic brain anomaly
* Has hydrocephalus or intraventricular hemorrhage \> Grade 3 or 4
* Is anemic (hemoglobin \< 8g/dL)
* Has an infection at time of study
* Is undergoing therapeutic hypothermia

Eligible Sex

ALL

Accepts Healthy Volunteers

No