Clinical trial NCT01643057: Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health
Official title: Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apnea of Prematurity
Keywords: Apnea
Prematurity
Biomarkers
Stochastic Resonance
Neonatal
Lead sponsor: Wyss Institute at Harvard University
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: University of Massachusetts, Worcester
First posted: 2012-07-17
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants currently inpatient in the Neonatal Intensive Care Unit at Beth Israel Deaconess Medical Center.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Investigate effects of mattress intervention on breathing patterns
timeFrame: Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.
Secondary outcomes:
measure: Candidate Biomarkers for Apnea of Prematurity
timeFrame: Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Vincent C Smith, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UMASS Medical School
name: David Paydarfar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith VC, Kelty-Stephen D, Qureshi Ahmad M, Mao W, Cakert K, Osborne J, Paydarfar D. Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial. Pediatrics. 2015 Dec;136(6):e1561-8. doi: 10.1542/peds.2015-1334.