Relationship Between EIT and Respiratory Status in Very Preterm Infants
NCT ID: NCT06609135
Last Updated: 2025-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-11-04
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Electrical Impedance Tomography (EIT) and CO2 monitor
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.
Sentec LuMon Device (EIT system)
Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.
Sentec Digital Monitoring System (transcutaneous CO2 monitor)
Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
Interventions
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Sentec LuMon Device (EIT system)
Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.
Sentec Digital Monitoring System (transcutaneous CO2 monitor)
Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.
Eligibility Criteria
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Inclusion Criteria
* Born between 25+0- and 29+6-weeks of gestation
Exclusion Criteria
* Infants with severe hemodynamic instability
5 Days
ALL
No
Sponsors
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SenTec AG, Ringstrasse 39, CH-4106 Therwil
UNKNOWN
Lawrence Rhein
OTHER
Responsible Party
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Lawrence Rhein
Chair, Department of Pediatrics
Principal Investigators
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Lawrence Rhein, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
UMASS Chan Medical School
Locations
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UMASS Memorial Medical Center
Worcester, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY00001180
Identifier Type: -
Identifier Source: org_study_id
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