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NCT06609135 · ClinicalTrials.gov registry record · NA
Relationship Between EIT and Respiratory Status in Very Preterm Infants
A NA study of Bronchopulmonary Dysplasia and Premature Lungs, sponsored by Lawrence Rhein.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06609135: Completed NA study of Bronchopulmonary Dysplasia and Premature Lungs, sponsored by Lawrence Rhein.
NCT06609135 is a NA study of Bronchopulmonary Dysplasia and Premature Lungs that has completed, run by Lawrence Rhein. The registered enrollment target is 20 participants, below the 236-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06609135, a NA study of Bronchopulmonary Dysplasia and Premature Lungs, has completed, sponsored by Lawrence Rhein.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index (GI) and Functional Lung Space, measured at 31 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 32 weeks post menstrual age. GI, a measure of ventilation inhomogeneity, ranges from 0 (completely homogeneous) to 1 (completely inhomogeneous). Lower GI values are interpreted as better.
Conditions Studied
Interventions
- DEVICE Sentec LuMon Device (EIT system)
- DEVICE Sentec Digital Monitoring System (transcutaneous CO2 monitor)
Study Locations (1)
Massachusetts
- UMASS Memorial Medical Center - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-11-04 |
| Est. Completion | 2024-08-31 |
| Phase | NA |
What the finished NCT06609135 record still lists
NCT06609135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 236-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 2 interventions - of which Sentec LuMon Device (EIT system) is the first listed.
NCT06609135 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06609135 about?
NCT06609135 is a clinical study titled "Relationship Between EIT and Respiratory Status in Very Preterm Infants". 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 succes...
What is the current status of trial NCT06609135?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2023-11-04. Estimated completion is 2024-08-31.
What conditions does trial NCT06609135 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Premature Lungs, Chronic Lung Disease of Prematurity.
What interventions are being tested in trial NCT06609135?
The interventions under investigation include: Sentec LuMon Device (EIT system) (DEVICE), Sentec Digital Monitoring System (transcutaneous CO2 monitor) (DEVICE).
Who is sponsoring clinical trial NCT06609135?
This trial is sponsored by Lawrence Rhein, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06609135 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06609135's enrollment target sits among peer trials
20 28th of 29 higher than 2 of 29 other Bronchopulmonary Dysplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bronchopulmonary Dysplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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