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| Name | Class |
|---|---|
| SenTec AG, Ringstrasse 39, CH-4106 Therwil | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical Impedance Tomography (EIT) and CO2 monitor | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentec LuMon Device (EIT system) | Device | Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EIT Metric Global Inhomogeneity Index at 31 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age. | 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. | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks. |
| EIT Metric Global Inhomogeneity Index at 31 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age. | 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. | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks. |
| EIT Metric Functional Lung Space at 31 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| EIT Metric Global Inhomogeneity Index at 32 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age. | The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Rhein, MD, MPH | UMASS Chan Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01605 | United States |
The EIT and TCOM data, study methodology may be valuable for other clinical investigators and thus worth sharing.
The plan is to share all IPD the underlie the results of a publication within 6 months of publication.
Requests by other clinical investigators will be reviewed by with Lawrence Rhein or Mohammad Jaber and if deemed reasonable IPD to be shared.
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The enrollment period lasted from November 2023 through August 2024. Recruitment occured in the UMASS Memorial Medical Center NICU. 40 very preterm infants were screened, 37 were eligible, 33 were approached, and 20 were successfully enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | EIT Metric Global Inhomogeneity Index at 31 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age. | 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. | Data at 31 weeks was available for 3 of the 6 infants that weaned to room air at 32 weeks | Posted | Mean | Standard Deviation | score on a scale | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks. |
|
Adverse event data was collected from enrollment through study completion which coincides with discharge from NICU at 36-43 weeks postmenstrual age. Depending on birth gestational age and discharge from NICU, adverse events are recorded during a period of 6 weeks (highest eligible birth gestational age to youngest postmenstrual age at NICU discharge) to 18 weeks (lowest possible birth gestational age to oldest postmenstrual age at NICU discharge).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Missing data due to enrollment timing, research staff limitations. The primary outcome is missing data in 9 of 20 infants. The secondary outcomes are missing 4 of 14 and 3 of 10 respectively. There is also potential of measurement error/noise due to variations in belt positioning, infant movement, and interference from respiratory monitoring equipment. The small sample size restricted ability to detect significant differences especially in secondary objectives as few infants analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lawrence Rhein, Chair of Pediatrics at UMASS Chan Medical School | UMASS Chan Medical School | 5083346581 | lawrence.rhein@umassmemorial.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2023 | Aug 19, 2025 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 6, 2023 | Jun 23, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Sentec Digital Monitoring System (transcutaneous CO2 monitor) | Device | Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts. |
|
| 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks. |
| EIT Metric Functional Lung Space at 31 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age. | 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. | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks. |
| 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks. |
| EIT Metric Global Inhomogeneity Index at 32 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age. | The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 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. | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks. |
| EIT Metric Global Inhomogeneity Index at 34 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age. | The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 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. | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks. |
| EIT Metric Global Inhomogeneity Index at 34 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age. | The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 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. | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks. |
| EIT Metric Functional Lung Space at 32 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age. | The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 weeks post menstrual age. | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks. |
| EIT Metric Functional Lung Space at 32 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age. | The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 weeks post menstrual age. | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks. |
| EIT Metric Functional Lung Space at 34 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age. | The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 weeks post menstrual age. | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks. |
| EIT Metric Functional Lung Space at 34 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age. | The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 weeks post menstrual age. | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Birth Gestational Age | Mean | Standard Deviation | weeks |
|
| Birth Weight | Mean | Standard Deviation | grams |
|
| Vaginal Delivery | Count of Participants | Participants |
|
| Betamethasone complete | Count of Participants | Participants |
|
| Postnatal Diuretics | Count of Participants | Participants |
|
| Postnatal Steroids | Count of Participants | Participants |
|
| Chronic Lung Disease of Prematurity | Count of Participants | Participants |
|
| 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. |
|
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| Primary | EIT Metric Global Inhomogeneity Index at 31 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age. | 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. | Data at 31 weeks was available for 8 of 14 infants that did not wean to room air at 32 weeks | Posted | Mean | Standard Deviation | score on a scale | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks. |
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| Secondary | EIT Metric Global Inhomogeneity Index at 32 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age. | The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 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. | Data at 32 weeks was available for all 4 infants that weaned to room air at 33 weeks. | Posted | Mean | Standard Deviation | score on a scale | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks. |
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| Secondary | EIT Metric Global Inhomogeneity Index at 32 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age. | The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 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. | Data at 32 weeks was available for 6 of 10 infants that did not wean to room air at 33 weeks | Posted | Mean | Standard Deviation | score on a scale | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks. |
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| Secondary | EIT Metric Global Inhomogeneity Index at 34 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age. | The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 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. | Data at 34 weeks was available for 3 of the 4 infants that weaned to room air by 36 weeks | Posted | Mean | Standard Deviation | score on a scale | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks. |
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| Secondary | EIT Metric Global Inhomogeneity Index at 34 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age. | The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 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. | Data at 34 weeks was available for 4 of the 6 infants that did not wean to room air by 36 weeks | Posted | Mean | Standard Deviation | score on a scale | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks. |
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| Primary | EIT Metric Functional Lung Space at 31 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age. | 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. | Data at 31 weeks was available for 3 of the 6 infants that weaned to room air at 32 weeks | Posted | Mean | Standard Deviation | percentage of total lung space | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks. |
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| Primary | EIT Metric Functional Lung Space at 31 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age. | 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. | Data at 31 weeks was available for 8 of the 14 infants that did not wean to room air at 32 weeks | Posted | Mean | Standard Deviation | percentage of total lung space | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 30+5/7 and 31+2/7 weeks postmenstrual age=up to 1-3 weeks. |
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| Secondary | EIT Metric Functional Lung Space at 32 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age. | The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 weeks post menstrual age. | Data at 32 weeks was available for all 4 infants that weaned to room air at 33 weeks. | Posted | Mean | Standard Deviation | percentage of total lung space | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks. |
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| Secondary | EIT Metric Functional Lung Space at 32 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 33 Weeks Post Menstrual Age. | The first secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 32 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 33 weeks post menstrual age. | Data at 32 weeks was available for 6 of 10 infants that did not wean to room air at 33 weeks | Posted | Mean | Standard Deviation | percentage of total lung space | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 31+5/7 and 32+2/7 weeks postmenstrual age=up to 2-4 weeks. |
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| Secondary | EIT Metric Functional Lung Space at 34 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age. | The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 weeks post menstrual age. | Data at 34 weeks was available for 3 of the 4 infants that weaned to room air by 36 weeks | Posted | Mean | Standard Deviation | percentage of total lung space | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks. |
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| Secondary | EIT Metric Functional Lung Space at 34 Weeks Post Menstrual Age in Those Unsuccessful in Discontinuation of Non-invasive Ventilation at 36 Weeks Post Menstrual Age. | The second secondary outcome is to determine whether electrical impedance tomography metrics, specifically Global Inhomogeneity Index and Functional Lung Space, measured at 34 weeks post menstrual age are associated with successful discontinuation of non-invasive ventilation at 36 weeks post menstrual age. | Data at 34 weeks was available for 4 of the 6 infants that did not wean to room air by 36 weeks | Posted | Mean | Standard Deviation | percentage of total lung space | 3-hour continuous measurement semi-weekly from 28+0/7 weeks or 7 days postnatally if older than 27+1/7 weeks birth gestational age to establish baseline. Comparative measurement obtained between 33+5/7 and 34+2/7 weeks postmenstrual age=up to 4-6 weeks. |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
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| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |