Passive Infrasound-to-ultrasound Vibrome Biosignatures of Lung Development in Newborn Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prematurity
- Sponsor
- Level 42 AI, Inc.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Gestational age change in lung vibroacoustics
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible participants include all infants admitted to the NICU.
Exclusion Criteria
- •There are no exclusions to enrollment in this study.
Outcomes
Primary Outcomes
Gestational age change in lung vibroacoustics
Time Frame: through study completion, an average of 6 weeks
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.