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PI has left Institution
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This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP) respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without oscillations. This will be measured by need for change to ventilator support, improvement in pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP, time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of study to end of respiratory treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal CPAP | Active Comparator | Standard Nasal CPAP |
|
| Oscillatory NCPAP | Active Comparator | NCPAP will be given to infant via prongs in the infant's nose. A Bird Industries pneumatic oscillating diaphragm to drive a Bird Industries phasatron which is attached by T-connector to the NCPAP patient circuit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal CPAP | Device | NCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP | Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP | 2 months |
| Need for mechanical ventilation following the initiation of NCPAP. | The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total duration of non-invasive and invasive respiratory support in each study group. | Determine the total duration of non-invasive and invasive respiratory support in each study group. | 2 months |
| total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Null, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Children's Healthcare | Madera | California | 93636 | United States | ||
| Primary Children's Medical Center |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007752 | Obstetric Labor, Premature |
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| Oscillatory NCPAP | Device | Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations. |
|
|
Determine the total amount of oxygen exposure in each study group. |
| 2 months |
| Salt Lake City |
| Utah |
| 84113 |
| United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |