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The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. Nevertheless, NIPPV has never been used in chinese babies.
The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIPPV | Active Comparator | The NIPPV group receiving NIPPV treatment. |
|
| Control | Active Comparator | The Control group receiving nCPAP treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIPPV | Device | Ventilator is Bird VIP. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. | At 7 days after non-invasive respiratorynsupport. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age. | At 7 days, 28 days and at 36 weeks postmenstraul age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuan Shi, MD | Department of Pediatrics, Daping Hospital, Third Military Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24039148 | Derived | Shi Y, Tang S, Zhao J, Shen J. A prospective, randomized, controlled study of NIPPV versus nCPAP in preterm and term infants with respiratory distress syndrome. Pediatr Pulmonol. 2014 Jul;49(7):673-8. doi: 10.1002/ppul.22883. Epub 2013 Sep 4. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| NIPPV |
| Device |
Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group. |
|
| NIPPV | Device | Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition. |
|