Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-01 @ 11:54 AM
Study NCT ID:
NCT06609135
Status:
COMPLETED
Last Update Posted:
2025-10-09
First Post:
2024-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Relationship Between EIT and Respiratory Status in Very Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lawrence.rhein@umassmemorial.org', 'phone': '5083346581', 'title': 'Dr. Lawrence Rhein, Chair of Pediatrics at UMASS Chan Medical School', 'organization': 'UMASS Chan Medical School'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '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).', 'eventGroups': [{'id': 'EG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'spread': '0.03', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of GI values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 31 weeks was available for 3 of the 6 infants that weaned to room air at 32 weeks'}, {'type': 'PRIMARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.13', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of GI values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 31 weeks was available for 8 of 14 infants that did not wean to room air at 32 weeks'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'spread': '0.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of GI values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 32 weeks was available for all 4 infants that weaned to room air at 33 weeks.'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '0.12', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of GI values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 32 weeks was available for 6 of 10 infants that did not wean to room air at 33 weeks'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of GI values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 34 weeks was available for 3 of the 4 infants that weaned to room air by 36 weeks'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'spread': '0.09', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of GI values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 34 weeks was available for 4 of the 6 infants that did not wean to room air by 36 weeks'}, {'type': 'PRIMARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of FLS values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'percentage of total lung space', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 31 weeks was available for 3 of the 6 infants that weaned to room air at 32 weeks'}, {'type': 'PRIMARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'spread': '11', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of FLS values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'percentage of total lung space', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 31 weeks was available for 8 of the 14 infants that did not wean to room air at 32 weeks'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'spread': '8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of FLS values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'percentage of total lung space', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 32 weeks was available for all 4 infants that weaned to room air at 33 weeks.'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'spread': '10', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of FLS values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'percentage of total lung space', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 32 weeks was available for 6 of 10 infants that did not wean to room air at 33 weeks'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of FLS values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'percentage of total lung space', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 34 weeks was available for 3 of the 4 infants that weaned to room air by 36 weeks'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'spread': '8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000'], 'groupDescription': 'Statistical Analysis assessed correlation of GI values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'percentage of total lung space', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data at 34 weeks was available for 4 of the 6 infants that did not wean to room air by 36 weeks'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Electrical Impedance Tomography (EIT) and CO2 Monitor', 'description': '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.\n\nSentec LuMon Device (EIT system): Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.\n\nSentec Digital Monitoring System (transcutaneous CO2 monitor): Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Birth Gestational Age', 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'spread': '1.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Birth Weight', 'classes': [{'categories': [{'measurements': [{'value': '1124', 'spread': '280', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vaginal Delivery', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Betamethasone complete', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Postnatal Diuretics', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Postnatal Steroids', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic Lung Disease of Prematurity', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-20', 'size': 206411, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_004.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-19T13:44', 'hasProtocol': True}, {'date': '2023-06-06', 'size': 208599, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-23T16:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2024-06-24', 'resultsFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-22', 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '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.', 'description': '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.'}, {'measure': '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.', 'timeFrame': '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.', 'description': '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.'}, {'measure': '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.', 'timeFrame': '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.', 'description': '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': '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.', 'timeFrame': '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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '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.', 'description': '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.'}, {'measure': '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.', 'timeFrame': '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.', 'description': '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.'}, {'measure': '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.', 'timeFrame': '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.', 'description': '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.'}, {'measure': '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.', 'timeFrame': '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.', 'description': '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.'}, {'measure': '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.', 'timeFrame': '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.', 'description': '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.'}, {'measure': '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.', 'timeFrame': '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.', 'description': '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.'}, {'measure': '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.', 'timeFrame': '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.', 'description': '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.'}, {'measure': '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.', 'timeFrame': '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.', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Electrical Impedance Tomography (EIT)', 'Prematurity', 'Pulmonary Function Testing', 'Noninvasive ventilation', 'Continuous Positive Airway Pressure (CPAP)', 'Transcutaneous CO2 monitor (TCOM)'], 'conditions': ['Chronic Lung Disease of Prematurity', 'Bronchopulmonary Dysplasia', 'Premature Lungs']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants admitted to the University of Massachusetts Memorial Medical Center (UMMMC) Neonatal Intensive Care Unit (NICU)\n* Born between 25+0- and 29+6-weeks of gestation\n\nExclusion Criteria:\n\n* Infants with major congenital anomalies\n* Infants with severe hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT06609135', 'briefTitle': 'Relationship Between EIT and Respiratory Status in Very Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Relationship Between Electrical Impedance Tomography (EIT) Measurements and Parameters of Respiratory Status in Very Preterm Infants: An Observational Cohort Study', 'orgStudyIdInfo': {'id': 'STUDY00001180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrical Impedance Tomography (EIT) and CO2 monitor', 'description': '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.', 'interventionNames': ['Device: Sentec LuMon Device (EIT system)', 'Device: Sentec Digital Monitoring System (transcutaneous CO2 monitor)']}], 'interventions': [{'name': 'Sentec LuMon Device (EIT system)', 'type': 'DEVICE', 'description': 'Sentec EIT belts will be placed on infants up to once daily from consent through NICU discharge.', 'armGroupLabels': ['Electrical Impedance Tomography (EIT) and CO2 monitor']}, {'name': 'Sentec Digital Monitoring System (transcutaneous CO2 monitor)', 'type': 'DEVICE', 'description': 'Sentec transcutaneous CO2 monitors will be placed on infants concurrently with EIT belts.', 'armGroupLabels': ['Electrical Impedance Tomography (EIT) and CO2 monitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMASS Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Lawrence Rhein, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMASS Chan Medical School'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'The plan is to share all IPD the underlie the results of a publication within 6 months of publication.', 'ipdSharing': 'YES', 'description': 'The EIT and TCOM data, study methodology may be valuable for other clinical investigators and thus worth sharing.', 'accessCriteria': 'Requests by other clinical investigators will be reviewed by with Lawrence Rhein or Mohammad Jaber and if deemed reasonable IPD to be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lawrence Rhein', 'class': 'OTHER'}, 'collaborators': [{'name': 'SenTec AG, Ringstrasse 39, CH-4106 Therwil', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chair, Department of Pediatrics', 'investigatorFullName': 'Lawrence Rhein', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}