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Relationship Between EIT and Respiratory Status in Very Preterm Infants

NCT06609135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-09

Study results available
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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

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.

Sponsors & Collaborators

  • SenTec AG, Ringstrasse 39, CH-4106 Therwil

    collaborator UNKNOWN

  • Lawrence Rhein

    lead OTHER

Principal Investigators

  • Lawrence Rhein, MD, MPH · UMASS Chan Medical School

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-04
Primary Completion
2024-08-31
Completion
2024-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06609135 on ClinicalTrials.gov