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The purpose of this study is to determine if among infants <30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP without weaning pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discontinue NCPAP after weaning pressures | Active Comparator | After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2). |
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| Discontinue NCPAP without weaning pressures | Active Comparator | After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discontinue NCPAP after weaning pressures | Device | After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days on NCPAP or Mechanical Ventilation | Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported. | from randomization until 28 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Endotracheal Ventilation | Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported. | from randomization until 28 days post-randomization |
| Number of Participants Who Failed to Wean Off NCPAP |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brittany Duyka, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Discontinue NCPAP After Weaning Pressures | After randomization, continuous positive airway pressure (CPAP) will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter (1L) flow, 30% FiO2). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Nov 13, 2017 |
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| Discontinue NCPAP without weaning pressures | Device | After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2). |
|
| from randomization until discharge (about 92 days) |
| Number of Participants Who Developed Bronchopulmonary Dysplasia | from randomization until discharge (about 92 days) |
| Number of Participants Who Developed Necrotizing Enterocolitis | from randomization until discharge (about 92 days) |
| Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth | from randomization until discharge (about 92 days) |
| Length of Hospital Stay | from admission to hospital until discharge (about 92 days) |
| Number of Participants Who Developed Air Leak Disorders | Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema. | from randomization until discharge (about 92 days) |
| FG001 | Discontinue NCPAP Without Weaning Pressures | After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter (1L) flow, 30% FiO2). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Discontinue NCPAP After Weaning Pressures | After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2). Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. |
| BG001 | Discontinue NCPAP Without Weaning Pressures | After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2). Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | corrected gestational age (in weeks) is reported | Mean | Full Range | weeks |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Number of Days on NCPAP or Mechanical Ventilation | Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported. | Posted | Mean | 95% Confidence Interval | days | from randomization until 28 days post-randomization |
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| Secondary | Duration of Endotracheal Ventilation | Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported. | Data for this measure was not collected. | Posted | from randomization until 28 days post-randomization |
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| Secondary | Number of Participants Who Failed to Wean Off NCPAP | Posted | Count of Participants | Participants | from randomization until discharge (about 92 days) |
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| Secondary | Number of Participants Who Developed Bronchopulmonary Dysplasia | Posted | Count of Participants | Participants | from randomization until discharge (about 92 days) |
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| Secondary | Number of Participants Who Developed Necrotizing Enterocolitis | Posted | Count of Participants | Participants | from randomization until discharge (about 92 days) |
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| Secondary | Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth | Posted | Mean | 95% Confidence Interval | number of days of life | from randomization until discharge (about 92 days) |
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| Secondary | Length of Hospital Stay | Posted | Mean | 95% Confidence Interval | days | from admission to hospital until discharge (about 92 days) |
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| Secondary | Number of Participants Who Developed Air Leak Disorders | Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema. | Posted | Count of Participants | Participants | from randomization until discharge (about 92 days) |
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from randomization until discharge (about 92 days)
Only events thought to be related to the intervention are considered to be adverse events.
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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 | Discontinue NCPAP After Weaning Pressures | After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2). Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG001 | Discontinue NCPAP Without Weaning Pressures | After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2). Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2). | 0 | 31 | 0 | 31 | 0 | 31 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amir Khan, MD | The University of Texas Health Science Center at Houston | 713-500-5519 | Amir.M.Khan@uth.tmc.edu |
| Feb 21, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
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