Vibroacoustic Study of Lung Development in Newborn Infants

NCT05827250 | Unknown

• 1 other identifier: L42CVP-0007
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

infrasound; vibrome; vibroacoustics

Outcome Measures

Primary Outcomes (1)

• Gestational age change in lung vibroacoustics

  Correlate the relationship of vibroacoustic measurements (i.e., vibroacoustic wave's maximum pressure fluctuations, represented by the base unit known as a Pascal) with gestational age (wks) as modified by clinical status.

  through study completion, an average of 6 weeks

Study Arms (1)

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

Interventions

imPulse Tor DEVICE

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.

Also known as: imPulse Tor infrasound-to-ultrasound e-stethoscope plus multi-lead ECG

Neonatal Profile

Eligibility Criteria

• Age: 0 Years - 2 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All infants admitted to the NICU

You may qualify if:

• Eligible participants include all infants admitted to the NICU.

Sponsors & Collaborators

• Level 42 AI, Inc.: lead
• Georgetown University: collaborator

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Pinaki Panigrahi, MD, PhD

  Georgetown University Medical Center Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pinaki Panigrahi, MD, PhD

CONTACT

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

Suhasini Kaushal, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: April 25, 2023
• Study Start: February 13, 2023
• Primary Completion: September 28, 2024
• Study Completion: February 28, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

US (1)