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Completed

NCT Number: NCT01643057

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stochastic Resonance Mattress

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.

Primary outcomes

  1. Investigate effects of mattress intervention on breathing patterns

    Time frame: Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.

    Focus on inter-breath intervals and oxygen desaturation.

Secondary outcomes

  1. Candidate Biomarkers for Apnea of Prematurity

    Time frame: Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.

    Candidate biomarkers in cardio-pulmonary, temperature, audiometry, photometry and clinical assessment data.

Sponsors and collaborators

Lead sponsor

Wyss Institute at Harvard University

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • University of Massachusetts, Worcester

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2012
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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