NCT06609135

Relationship Between EIT and Respiratory Status in Very Preterm Infants

Relationship Between Electrical Impedance Tomography (EIT) Measurements and Parameters of Respiratory Status in Very Preterm Infants: An Observational Cohort Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Lawrence Rhein · Academic / Other
• Sex: All
• Age: 5 Days
• Healthy volunteers: Not accepted

Summary

Electrical Impedance Tomography (EIT) is a non-invasive imaging technique that can measure lung function in real time. This study will follow premature infants to see if EIT can help predict which infants will be successful in weaning off respiratory support by 32-33 weeks gestational age. If successful, EIT could be used to develop new guidelines for respiratory support in premature infants.

Conditions

• Chronic Lung Disease of Prematurity
• Bronchopulmonary Dysplasia
• Premature Lungs

Interventions

Type	Name	Description
DEVICE	Sentec LuMon Device (EIT system)	Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.
DEVICE	Sentec Digital Monitoring System (transcutaneous CO2 monitor)	Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.

Timeline

• Start date: 2023-11-04
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2024-09-24
• Last updated: 2025-10-09
• Results posted: 2025-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study