Vibroacoustic Study of Lung Development in Newborn Infants

Level 42 AI

Status: Enrolling

Conditions: Prematurity; Prematurity; Extreme; Premature Lungs; Premature Birth

Treatments: Device: imPulse Tor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05827250

L42CVP-0007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible participants include all infants admitted to the NICU.

Exclusion criteria

• There are no exclusions to enrollment in this study.

Trial design

200 participants in 1 patient group

Neonatal Profile

Description:

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.

Treatment:

Device: imPulse Tor