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

Apnea of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643057
• Other study ID #: AMD-CS-0015
• Status: Completed
• Phase: N/A
• First received: July 13, 2012
• Last updated: September 9, 2015
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: September 2015
• Source: Wyss Institute at Harvard University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea of Prematurity
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconness Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Wyss Institute at Harvard University	Beth Israel Deaconess Medical Center, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No