Vibroacoustic Study of Lung Development in Newborn Infants

Premature Birth Clinical Trial

Official title:

Passive Infrasound-to-ultrasound Vibrome Biosignatures of Lung Development in Newborn Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827250
• Other study ID #: L42CVP-0007
• Status: Recruiting
• Start date: February 13, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2023
• Source: Level 42 AI, Inc.
• Contact: Pinaki Panigrahi, MD, PhD
• Phone: (2020) 444-5553
• Email: pinaki.panigrahi[@]georgetown.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2025
• Est. primary completion date: September 28, 2024
• Gender: All
• Age group: 0 Years to 2 Years

Eligibility

Inclusion Criteria:

• Eligible participants include all infants admitted to the NICU.

Exclusion Criteria:

• There are no exclusions to enrollment in this study.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Level 42 AI, Inc.	Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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