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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| University of Massachusetts, Worcester | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate effects of mattress intervention on breathing patterns | Focus on inter-breath intervals and oxygen desaturation. | Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Candidate Biomarkers for Apnea of Prematurity | Candidate biomarkers in cardio-pulmonary, temperature, audiometry, photometry and clinical assessment data. | Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions. |
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Inclusion Criteria:
Eligible subjects are infants currently inpatient in the NICU at Beth Israel Deaconess Medical Center and:
Exclusion Criteria:
Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:
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Infants currently inpatient in the Neonatal Intensive Care Unit at Beth Israel Deaconess Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Vincent C Smith, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| David Paydarfar, MD | UMASS Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconness Medical Center | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26598451 | Derived | 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. |
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| ID | Term |
|---|---|
| D001049 | Apnea |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |