Relationship Between EIT and Respiratory Status in Very Preterm Infants

Not Applicable

Completed

• Conditions: Chronic Lung Disease of Prematurity; Bronchopulmonary Dysplasia; Premature Lungs
• Interventions: Device: Sentec LuMon Device (EIT system); Device: Sentec Digital Monitoring System (transcutaneous CO2 monitor)

• Registration Number: NCT06609135
• Lead Sponsor: Lawrence Rhein

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-04
• Study First Submitted: 2024-06-24
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Infants admitted to the UMass 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrical Impedance Tomography (EIT) and CO2 monitor	Sentec LuMon Device (EIT system)	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.
Electrical Impedance Tomography (EIT) and CO2 monitor	Sentec Digital Monitoring System (transcutaneous 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.

Primary Outcome Measures

Name	Time	Method
Discontinuation of respiratory support at 32 weeks corrected gestational age	At 32 weeks corrected gestational age	Successful discontinuation of non-invasive ventilation at 32 weeks corrected gestational age.
Discontinuation of respiratory support at 33 weeks corrected gestational age	At 33 weeks corrected gestational age	Successful discontinuation of non-invasive ventilation at 33 weeks corrected gestational age.
Change in EIT measurements with titration of noninvasive respiratory support	Until positive end expiratory pressure support is discontinued, approximately 3 weeks	EIT values at set positive end expiration pressure levels.
Correlation between EIT measurements and TCOM measurements	Through study completion, an average of 8 weeks	Mean transcutaneous CO2 levels
Correlation between EIT measurements and time to full oral feeding	Through study completion, an average of 8 weeks	Duration of time required for successful full oral feeding.
Correlation between EIT measurements and BPD status at 36 weeks	At 36 weeks corrected gestational age	Bronchopulmonary dysplasia (BPD) status at 36 weeks corrected gestation.

Trial Locations

Locations (1)

UMASS Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States