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.

Study Overview

• Status: Completed
• Conditions: Apnea of Prematurity
• Intervention / Treatment: Device: Stochastic Resonance Mattress

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
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconness Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 13, 2012
• First Submitted That Met QC Criteria: July 13, 2012
• First Posted (Estimate): July 17, 2012

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 9, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Biomarkers; Prematurity; Neonatal; Apnea; Stochastic Resonance
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: AMD-CS-0015