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
  Purpose

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


Condition Intervention
Apnea of Prematurity
Device: Stochastic Resonance Mattress

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health

Resource links provided by NLM:


Further study details as provided by Wyss Institute at Harvard University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 36
Study Start Date: July 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643057

Locations
United States, Massachusetts
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Wyss Institute at Harvard University
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
  More Information

No publications provided

Responsible Party: Wyss Institute at Harvard University
ClinicalTrials.gov Identifier: NCT01643057     History of Changes
Other Study ID Numbers: AMD-CS-0015
Study First Received: July 13, 2012
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wyss Institute at Harvard University:
Apnea
Prematurity
Biomarkers
Stochastic Resonance
Neonatal

ClinicalTrials.gov processed this record on October 20, 2014