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Vibroacoustic Study of Lung Development in Newborn Infants

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05827250
Enrollment
200
Registered
2023-04-25
Start date
2023-02-13
Completion date
2025-02-28
Last updated
2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth, Premature Lungs, Prematurity, Prematurity; Extreme

Keywords

infrasound, vibrome, vibroacoustics

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.

Interventions

DEVICEimPulse 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.

Sponsors

Georgetown University
CollaboratorOTHER
Level 42 AI, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 2 Years

Inclusion criteria

* Eligible participants include all infants admitted to the NICU.

Exclusion criteria

* There are no exclusions to enrollment in this study.

Design outcomes

Primary

MeasureTime frameDescription
Gestational age change in lung vibroacousticsthrough study completion, an average of 6 weeksCorrelate 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.

Countries

United States

Contacts

Primary ContactPinaki Panigrahi, MD, PhD
pinaki.panigrahi@georgetown.edu(2020) 444-5553
Backup ContactSuhasini Kaushal, MD
Suhasini.Kaushal@gunet.georgetown.edu(202) 444-8569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026