Vibroacoustic Study of Lung Development in Newborn Infants

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

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth; Prematurity; Premature Lungs; Prematurity; Extreme
• Intervention / Treatment: Device: imPulse Tor

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Pinaki Panigrahi, MD, PhD; Phone Number: (2020) 444-5553; Email: pinaki.panigrahi@georgetown.edu
• Study Contact Backup: Name: Suhasini Kaushal, MD; Phone Number: (202) 444-8569; Email: Suhasini.Kaushal@gunet.georgetown.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • MedStar Georgetown University Hospital
      • Contact: Suhasini Kaushal, MD; Phone Number: (202) 444-8569; Email: Suhasini.Kaushal@gunet.georgetown.edu
      • Contact: Pinaki Panigrahi, MD, PhD; Phone Number: 202-444-5553; Email: pinaki.panigrahi@georgetown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All infants admitted to the NICU

Description

Inclusion Criteria:

• Eligible participants include all infants admitted to the NICU.

Exclusion Criteria:

• There are no exclusions to enrollment in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other Names: imPulse Tor infrasound-to-ultrasound e-stethoscope plus multi-lead ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Level 42 AI, Inc.
• Collaborators: Georgetown University
• Investigators: Principal Investigator: Pinaki Panigrahi, MD, PhD, Georgetown University Medical Center Pediatrics

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Anticipated): September 28, 2024
• Study Completion (Anticipated): February 28, 2025

Study Registration Dates

• First Submitted: March 18, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: infrasound; vibroacoustics; vibrome
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: L42CVP-0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data sharing language not included in consent for this pilot study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No