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This study is a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' < 30 weeks of gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIV-NAVA | Active Comparator | Noninvasive ventilation in this group is practiced with NIV-NAVA |
|
| N-CPAP | Active Comparator | Patients in this group will receive nasal continuous positive airway pressure as routinely in neonatal intensive care unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIV-NAVA | Device | Non-invasive neurally adjusted ventilatory assist |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Extubation failure | Failure criteria
| extubation - 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation | Participants will be followed for the extubation failure within 3 days after extubation | extubation - 72 hours |
| Severe apnea event requiring bag and mask resuscitation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han-Suk Kim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Children's Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35460702 | Derived | Shin SH, Shin SH, Kim SH, Song IG, Jung YH, Kim EK, Kim HS. Noninvasive Neurally Adjusted Ventilation in Postextubation Stabilization of Preterm Infants: A Randomized Controlled Study. J Pediatr. 2022 Aug;247:53-59.e1. doi: 10.1016/j.jpeds.2022.04.025. Epub 2022 Apr 20. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| N-CPAP |
| Device |
Nasal-continuous positive airway pressure |
|
Participants will be followed for the extubation failure within 3 days after extubation
| extubation - 72 hours |
| FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation | Participants will be followed for the extubation failure within 7 days after extubation | extubation - 7 days |
| pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings | Participants will be followed for the extubation failure within 7 days after extubation | extubation - 7 days |
| Severe apnea event requiring bag and mask resuscitation | Participants will be followed for the extubation failure within 7 days after extubation | extubation - 7 days |
| Bronchopulmonary dysplasia | Participants will be followed for the duration of hospital stay | postmenstrual age 36 weeks |
| Duration of noninvasive ventilation | Participants will be followed for the duration of hospital stay | postmenstrual age 40 weeks (until discharge) |
| Duration of inspired oxygen supply | Participants will be followed for the duration of hospital stay | postmenstrual age 40 weeks (until discharge) |
| Duration of hospital stay | Participants will be followed for the duration of hospital stay | postmenstrual age 40 weeks (until discharge) |
| Adverse events | Participants will be followed for 3 days after extubation | extubation - 3days |
| D000091642 | Urogenital Diseases |