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

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Wyss Institute at Harvard University
ClinicalTrials.gov Identifier:
NCT01643057
First received: July 13, 2012
Last updated: September 23, 2014
Last verified: September 2014

July 13, 2012
September 23, 2014
July 2012
July 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Focus on inter-breath intervals and oxygen desaturation.
Same as current
Complete list of historical versions of study NCT01643057 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Candidate biomarkers in cardio-pulmonary, temperature, audiometry, photometry and clinical assessment data.
Candidate Biomarkers for Apnea of Prematurity [ Time Frame: Participants will be tested for 6-24 hours ] [ Designated as safety issue: No ]
Candidate biomarkers in cardio-pulmonary, temperature, audiometry, photometry and clinical assessment data.
Not Provided
Not Provided
 
Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Infants currently inpatient in the Neonatal Intensive Care Unit at Beth Israel Deaconess Medical Center.

Apnea of Prematurity
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01643057
AMD-CS-0015
No
Wyss Institute at Harvard University
Wyss Institute at Harvard University
  • Beth Israel Deaconess Medical Center
  • University of Massachusetts, Worcester
Principal Investigator: Vincent C Smith, MD, MPH Beth Israel Deaconess Medical Center
Principal Investigator: David Paydarfar, MD UMASS Medical School
Wyss Institute at Harvard University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP