Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health
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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 |
- 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.
- 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (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| Ages Eligible for Study: | up to 10 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Infants currently inpatient in the Neonatal Intensive Care Unit at Beth Israel Deaconess Medical Center.
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
- Are at a Post Conceptual Age of < 45 weeks at time of study (Calculated as: weeks of age at birth + weeks of age since birth)
- Have had at least one documented clinical apnea (> 20 seconds), irregular breathing, bradycardia (< 100 bpm) and/or desaturation (< 90%) within 72 hours prior to first study session
Exclusion Criteria:
Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:
- 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 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| Contact: Mona Qureshi, BS, CCRP | 617-432-1578 | mona.qureshi@wyss.harvard.edu |
| United States, Massachusetts | |
| Beth Israel Deaconness Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Vincent C Smith, MD, MPH | |
| Sub-Investigator: Mona Qureshi, BS, CCRP | |
| Sub-Investigator: John Osborne, MS | |
| Sub-Investigator: Damian Kelty-Stephen, Ph.D | |
| 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: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wyss Institute at Harvard University:
|
Apnea Prematurity Biomarkers Stochastic Resonance Neonatal |
Additional relevant MeSH terms:
|
Apnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013