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Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Currently, a premature baby has to be ventilated through an endotracheal tube until he/she can fully breathe independently. In the current study, in order to shorten the time with an endotracheal tube, we utilized an alternative, less invasive ventilation procedure, nasal intermittent positive pressure ventilation (NIPPV). This procedure provides help with breathing, but requires only nasal, not endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage in their recovery, when they could not breathe independently yet. Thus, by switching babies at this early stage from a regular respirator to NIPPV, we should be able to shorten the use of an injurious endotracheal tube.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIPPV | Experimental | Extubation to NIPPV (nasal intermittent positive pressure ventilation) |
|
| CPAP | Active Comparator | After extubation this arm was placed on CPAP (continuous positive airway pressure) and was not offered NIPPV in the first month on life |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extubation to NIPPV | Procedure | After extubation infants were placed on NIPPV as soon as all the extubation criteria were met |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Being Intubated | 30 days from birth |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Reintubation | Reintubation rate is a measure of the efficacy of NIPPV. | 0-7 days post-extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga A DeSimone, MD | The Floating Hospital for Children at Tufts Medical Center | Principal Investigator |
| Abbot R Laptook, MD | Women and Infants Hospital of RI | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women and Infants Hospital of RI | Providence | Rhode Island | 02905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NIPPV | Extubation to NIPPV (nasal intermittent positive pressure ventilation) |
| FG001 | CPAP | After extubation this arm was placed on CPAP (continuous positive airway pressure)and was not offered NIPPV in the first month on life |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NIPPV | Extubation to NIPPV (nasal intermittent positive pressure ventilation) |
| BG001 | CPAP | After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life |
| 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 | Number of Days Being Intubated | Posted | Median | Full Range | days | 30 days from birth |
|
|
Participants were followed until discharge from the hospital for an average of 100 days.
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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 | NIPPV | Extubation to NIPPV (nasal intermittent positive pressure ventilation) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Death not related to NIPPV use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abbot R. Laptook, MD, Professor of Pediatrics The Warren Alpert Medical School of Brown University M | Women & Infants Hospital of Rhode Island | 401-274-1122 | 7404 | ALaptook@WIHRI.org |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D053120 | Respiratory Aspiration |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Extubation to CPAP | Procedure | After extubation infants were placed on CPAP |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Percentage of Participants With Reintubation | Reintubation rate is a measure of the efficacy of NIPPV. | Posted | Number | % of participants with reintubation | 0-7 days post-extubation |
|
|
|
| 2 |
| 16 |
| 0 |
| 16 |
| EG001 | CPAP | After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life | 3 | 18 | 0 | 18 |
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| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |