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

NCT01643057 | Completed

• 1 other identifier: AMD-CS-0015
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Apnea of Prematurity

Keywords

Apnea; Prematurity; Biomarkers; Stochastic Resonance; Neonatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Candidate Biomarkers for Apnea of Prematurity

  Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.

Study Arms (1)

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

Interventions

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.

Stochastic Resonance Mattress

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyss Institute at Harvard University: lead
• Beth Israel Deaconess Medical Center: collaborator
• University of Massachusetts, Worcester: collaborator

Study Sites (1)

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 26598451 DERIVED

MeSH Terms

Conditions

Apnea; Premature Birth

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vincent C Smith, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• David Paydarfar, MD

  UMASS Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 10, 2015

Record last verified: 2015-09

Locations

US (1)