N/A N=20 Diagnostic

Relationship Between EIT and Respiratory Status in Very Preterm Infants

Chronic Lung Disease of Prematurity · Bronchopulmonary Dysplasia · Premature Lungs

Bottom Line

View on ClinicalTrials.gov: NCT06609135 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: EIT Metric Global Inhomogeneity Index at 31 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age. — 0.54 score on a scale — p=0.045

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sentec LuMon Device (EIT system) (Device); Sentec Digital Monitoring System (transcutaneous CO2 monitor) (Device)
Age: Pediatric, Adult, Older Adult · 0+ yrs
Sex: All
Sponsor: Lawrence Rhein
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY EIT Metric Global Inhomogeneity Index at 31 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age.	0.54	0.045 sig
PRIMARY EIT Metric Global Inhomogeneity Index at 31 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age.	0.7	0.045 sig
PRIMARY EIT Metric Functional Lung Space at 31 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age.	85	0.09
PRIMARY EIT Metric Functional Lung Space at 31 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age.	71	0.09
SECONDARY EIT Metric Global Inhomogeneity Index at 32 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age.	0.62	0.49
SECONDARY EIT Metric Global Inhomogeneity Index at 32 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age.	0.67	0.49
SECONDARY EIT Metric Global Inhomogeneity Index at 34 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age.	0.55	0.56
SECONDARY EIT Metric Global Inhomogeneity Index at 34 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age.	0.59	0.56
SECONDARY EIT Metric Functional Lung Space at 32 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age.	79	0.44
SECONDARY EIT Metric Functional Lung Space at 32 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age.	74	0.44
SECONDARY EIT Metric Functional Lung Space at 34 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age.	85	0.59
SECONDARY EIT Metric Functional Lung Space at 34 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age.	81	0.59

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.

Eligibility Criteria

Inclusion Criteria

Infants admitted to the University of Massachusetts Memorial Medical Center (UMMMC) Neonatal Intensive Care Unit (NICU)
Born between 25+0- and 29+6-weeks of gestation

Exclusion Criteria

Infants with major congenital anomalies
Infants with severe hemodynamic instability

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06609135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.