Vibroacoustic Study of Lung Development in Newborn Infants

NCT ID: NCT05827250

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2025-02-28

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.

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.

Conditions

Prematurity; Premature Birth; Premature Lungs; Prematurity; Extreme

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

imPulse Tor

Intervention Type: 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.

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.

Intervention Type: DEVICE

Other Intervention Names

imPulse Tor infrasound-to-ultrasound e-stethoscope plus multi-lead ECG

Eligibility Criteria

Inclusion Criteria

• Eligible participants include all infants admitted to the NICU.

Exclusion Criteria

• There are no exclusions to enrollment in this study.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: collaborator

Level 42 AI, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pinaki Panigrahi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Medical Center Pediatrics

Locations

Medstar Georgetown University Hospital

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

Site Status: RECRUITING

Countries

United States

Central Contacts

Pinaki Panigrahi, MD, PhD

Role: CONTACT

pinaki.panigrahi@georgetown.edu

(2020) 444-5553

Suhasini Kaushal, MD

Role: CONTACT

Suhasini.Kaushal@gunet.georgetown.edu

(202) 444-8569

Facility Contacts

Pinaki Panigrahi, MD, PhD

Role: primary

pinaki.panigrahi@georgetown.edu

202-444-5553

Suhasini Kaushal, MD

Role: backup

Suhasini.Kaushal@gunet.georgetown.edu

(202) 444-8569

Other Identifiers

L42CVP-0007

Identifier Type: -

Identifier Source: org_study_id