Recruiting

Observational Study

Sponsor:

Level 42 AI, Inc.

Code:

NCT05827250

Conditions

Prematurity

Premature Birth

Premature Lungs

Prematurity; Extreme

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

imPulse Tor

Study Details

Brief 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

Study ID

NCT05827250

Start date

Feb 13, 2023

Status verified date

Apr, 2023

Completion date

Feb 28, 2025

Anticipated

Primary completion date

Sep 28, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Eligible participants include all infants admitted to the NICU.

Exclusion Criteria:

  • There are no exclusions to enrollment in this study.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Gestational age change in lung vibroacoustics [ Time Frame: through study completion, an average of 6 weeks ]

Central Contacts and Locations

Central contacts

Pinaki Panigrahi, MD, PhD

(2020) 444-5553pinaki.panigrahi@georgetown.edu

Suhasini Kaushal, MD

(202) 444-8569Suhasini.Kaushal@gunet.georgetown.edu

Locations

Medstar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Pinaki Panigrahi, MD, PhD

202-444-5553pinaki.panigrahi@georgetown.edu

Suhasini Kaushal, MD

(202) 444-8569Suhasini.Kaushal@gunet.georgetown.edu

More Information

Sponsor

Level 42 AI, Inc.

Last update posted

Apr 25, 2023

Last verified

Apr, 2023

Keywords

  • infrasound
  • vibrome
  • vibroacoustics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Level 42 AI, Inc. on 2023-04-25.