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

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.

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%)

Exclusion Criteria:

Eligible infants meeting the inclusion criteria above will be excluded from participation
in the study if he/she:

- 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