Vibroacoustic Study of Lung Development in Newborn Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prematurity, Premature Birth, Premature Lungs, Prematurity; Extreme

Intervention / Treatment
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* Device: imPulse Tor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants include all infants admitted to the NICU. Exclusion Criteria: There are no exclusions to enrollment in this study.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonatal Profile<br>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<br>* 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.<br>* Other names: imPulse Tor infrasound-to-ultrasound e-stethoscope plus multi-lead ECG;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infrasound, vibrome, vibroacoustics