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| Name | Class |
|---|---|
| Children's Hospital of Chongqing Medical University | OTHER |
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Invasive ventilation(IV) remains one key cornerstone to reduce neonatal mortality for preterm infants with respiratory distress syndrome(RDS) and/or acute respiratory distress syndrome(ARDS). However, it is also related to increased risks of ventilator-associated lung injury and escalation of pulmonary inflammation, and which finally result in bronchopulmonary dysplasia (BPD). Early weaning from IV in newborn infants with BPD is therefore a key procedure to reduce these risks above.
Supplying with the combined advantages of NCPAP and high-frequency oscillatory ventilation (HFOV) with high carbon dioxide(CO2) removal, no need for synchronisation, non-invasion, less volume/barotraumas, and increased functional residual capacity, nasal HFOV(NHFOV) was considered as a strengthened version of NCPAP. Furthermore, the superimposed oscillations of NHFOV could avoid gas-trapping, and allowed to obviously up-regulate mean airway pressure (MAP) more than NCPAP. Thus, NHFOV might be more beneficial as post-extubation respiratory support strategy to avoid re-intubation and subsequent complications and/or sequelae as compared with NCPAP in preterm infants. Nowadays, NHFOV was increasingly used in neonatal intensive care unit (NICU) around the world due to its convenient operation. A retrospective review has reported the beneficial effects of NHFOV in preterm infants as a remedial measure after failing to other noninvasive modes, including reducing the number of apneas, bradycardias or oxygen desaturations. However, there were rare randomized controlled studies comparing NHFOV with NCPAP in preterm infants with BPD.
We have found that NHFOV is superior to NCPAP in avoiding re-intubation in very preterm infants with the first extubation. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support strategies on the need for endotracheal ventilation, as well as pressure of CO2(PCO2) level in preterm infants with BPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NHFOV | Experimental | After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV |
|
| NCPAP | Active Comparator | After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NHFOV | Device | After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV |
|
| Measure | Description | Time Frame |
|---|---|---|
| re-intubation rate | the newborn infants with ventilated BPD is reintubated after extubation | seven days after extubation |
| death | the newborn infants with BPD die | seven days after extubation |
| the level of carbon dioxide | the level of carbon dioxide is measure after extubation between groups | seven days after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| necrotizing entercolitis(NEC) | the newborn infants with BPD is diagnosed with NEC | seven days after extubation |
| intraventricular hemorrhage(IVH) | the newborn infants with BPD is diagnosed with NEC |
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Inclusion Criteria:
Eligibility requirements for neonates:
Exclusion Criteria:
one of the following conditions is needed:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen(陈) Long, MD, PhD | Contact | +8613883559467 | neuroclong@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chen(陈) | Recruiting | Chongqing | Chongqing Municipality | 400014 | China |
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After documenting parental consent, the ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP
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After documenting parental consent, these ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP using a table of random numbers and sealed opaque envelopes when they were eligible for extubation. Blinding to doctor was not possible due to the nature of the intervention, is not necessary to participant.
| NCPAP | Device | After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP |
|
| seven days after extubation |
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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