NCT05827250

Vibroacoustic Study of Lung Development in Newborn Infants

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Level 42 AI, Inc. · Industry
• Sex: All
• Age: 0 Years – 2 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-13
• Primary completion: 2024-09-28
• Completion: 2025-02-28
• First posted: 2023-04-25
• Last updated: 2023-04-25

Locations

1 site across 1 country: United States