Relationship Between EIT and Respiratory Status in Very Preterm Infants

Lawrence Rhein

Status: Completed

Conditions: Chronic Lung Disease of Prematurity; Bronchopulmonary Dysplasia; Premature Lungs

Treatments: Device: Sentec Digital Monitoring System (transcutaneous CO2 monitor); Device: Sentec LuMon Device (EIT system)

Study type: Interventional

Funder types: Other

Identifiers

NCT06609135

STUDY00001180

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 5+ days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Electrical Impedance Tomography (EIT) and CO2 monitor

Experimental group

Description:

Participating infants will have the EIT belt placed at a minimum of twice per week throughout the NICU stay. A respiratory therapist or physician will place the EIT belt at the end of a feed and remove it at the next feed. A transcutaneous CO2 monitor will be placed concurrently.

Treatment:

Device: Sentec LuMon Device (EIT system)

Device: Sentec Digital Monitoring System (transcutaneous CO2 monitor)