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Purpose

Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes. Investigators further hypothesize that audible sounds combined with novel inaudible vibrations above and below human perception interpreted with transparent and auditable AI algorithms can detect and identify early gas and fluid movement anomalies not uncovered by conventional tools in an non-invasive, easy, fast, and low cost examination.

Conditions

Eligibility

Eligible Ages
Between 0 Years and 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Eligible participants include all infants admitted to the NICU.

Exclusion Criteria

  • There are no exclusions to enrollment in this study.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Neonatal Profile LUSS will be obtained twice a week on the following schedule for the duration of each subject's NICU stay. Day of life (DOL): 7+/-1, 10+/-1, and 14+/-1 Depending on length of stay, within +/-2 days of: DOL 17, 21, 24, 28, 31, 35, 38, 41, 44, 48, 51, 56, and 60.
  • Device: imPulse Tor
    The imPulse-Tor system passively collects audible sounds and inaudible vibrations spanning the infrasound-to-ultrasound frequency range, as well as cardiac electrical signals. The device can be safely placed directly on the chest wall to obtain readings. imPulse System vibroacoustic recording (VAR) will be performed twice daily till discharge. An attempt will be made to have at least a 6+/-2 hr gap between the two recordings.
    Other names:
    • imPulse Tor infrasound-to-ultrasound e-stethoscope plus multi-lead ECG

Recruiting Locations

Medstar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Pinaki Panigrahi, MD, PhD
202-444-5553
pinaki.panigrahi@georgetown.edu

More Details

Status
Recruiting
Sponsor
Level 42 AI, Inc.

Study Contact

Pinaki Panigrahi, MD, PhD
(2020) 444-5553
pinaki.panigrahi@georgetown.edu

Detailed Description

Worldwide preterm birth (<37 weeks of gestation) affects approximately 10% of live births and is the leading cause of death in children less than 5 years of age. Preterm birth disrupts normal lung development leading to several respiratory complications in the neonatal period and later in life. Consequently, factors that negatively affect prenatal and early life respiratory growth can compromise the achievement of "personal-best lung function". This novel study will generate normative, audible/inaudible frequencies, visible/invisible frequencies, and perceptible/imperceptible energies, termed vibrome biosignatures, of cardiopulmonary development and function during early postnatal development. Once baseline patterns are established, future studies will be designed to characterize vibrome biosignature differences across acute neonatal respiratory problems, such as respiratory distress syndrome, meconium aspiration, sepsis, persistent pulmonary hypertension, and congenital heart disease.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.