Vibroacoustic Study of Lung Development in Newborn Infants

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05827250
Study type	Observational
Source	Level 42 AI, Inc.
Contact	Pinaki Panigrahi, MD, PhD
Phone	(2020) 444-5553
Email	pinaki.panigrahi@georgetown.edu
Status	Recruiting
Phase
Start date	February 13, 2023
Completion date	February 28, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05048550` - Babies in Glasses; a Feasibility Study.	N/A
Active, not recruiting	`NCT03655639` - Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Enrolling by invitation	`NCT05542108` - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants	N/A
Completed	`NCT03680157` - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed	`NCT03337659` - A Cluster Randomized Controlled Trial of FICare at 18 Months	N/A
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Completed	`NCT03251729` - Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix	Phase 4
Not yet recruiting	`NCT05039918` - Neonatal Experience of Social Touch	N/A
Not yet recruiting	`NCT03418012` - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB	N/A
Not yet recruiting	`NCT03418311` - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome	N/A
Completed	`NCT02952950` - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study	N/A
Not yet recruiting	`NCT02880696` - Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates	N/A
Completed	`NCT02913495` - Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth	Phase 4
Completed	`NCT02879799` - Family Integrated Care (FICare) in Level II NICUs	N/A
Completed	`NCT02661360` - Effects of Swaddling on Infants During Feeding	N/A
Completed	`NCT02743572` - Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants	N/A
Completed	`NCT01352234` - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia	Phase 4
Completed	`NCT01163188` - Social Adjustment and Quality of Life After Very Preterm Birth	N/A
Terminated	`NCT00675753` - Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families	N/A
Completed	`NCT00271115` - Kangaroo Holding and Maternal Stress	N/A