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Vibroacoustic Study of Lung Development in Newborn Infants

NCT05827250 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-04-25

No results posted yet for this study

Summary

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

  • Prematurity
  • Premature Birth
  • Premature Lungs
  • Prematurity; Extreme

Interventions

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.

Sponsors & Collaborators

  • Georgetown University

    collaborator OTHER

  • Level 42 AI, Inc.

    lead INDUSTRY

Principal Investigators

  • Pinaki Panigrahi, MD, PhD · Georgetown University Medical Center Pediatrics

Eligibility

Min Age
0 Years
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2024-09-28
Completion
2025-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05827250 on ClinicalTrials.gov