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

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ClinicalTrials.gov Identifier: NCT01643057
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : September 10, 2015
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Wyss Institute at Harvard University

Tracking Information
First Submitted Date July 13, 2012
First Posted Date July 17, 2012
Last Update Posted Date September 10, 2015
Study Start Date July 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 23, 2014)
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.
Original Secondary Outcome Measures
 (submitted: July 13, 2012)
Candidate Biomarkers for Apnea of Prematurity [ Time Frame: Participants will be tested for 6-24 hours ]
Candidate biomarkers in cardio-pulmonary, temperature, audiometry, photometry and clinical assessment data.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health
Official Title Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants currently inpatient in the Neonatal Intensive Care Unit at Beth Israel Deaconess Medical Center.
Condition Apnea of Prematurity
Intervention 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.
Study Groups/Cohorts 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: Device: Stochastic Resonance Mattress
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 23, 2014)
36
Original Estimated Enrollment
 (submitted: July 13, 2012)
20
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01643057
Other Study ID Numbers AMD-CS-0015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyss Institute at Harvard University
Study Sponsor Wyss Institute at Harvard University
Collaborators
  • Beth Israel Deaconess Medical Center
  • University of Massachusetts, Worcester
Investigators
Principal Investigator: Vincent C Smith, MD, MPH Beth Israel Deaconess Medical Center
Principal Investigator: David Paydarfar, MD UMASS Medical School
PRS Account Wyss Institute at Harvard University
Verification Date September 2015